Fastener, Fixation, Nondegradable, Soft Tissue

FDA product code MBI · 558 cleared devices

Class 2 Orthopedic

Regulation: 21 CFR 888.3040
Review panel: OR
Implant: Yes
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1995-02-01 – 2026-09-17

MBI 2009-01-22

EXTREMITY MEDICAL SUTURE ANCHOR

Applicant Extremity Medical, LLC

K number K083151

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MBI 2009-01-15

G-FORCE TENODESIS SCREW

Applicant Wrightmedicaltechnologyinc

K number K083150

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MBI 2009-01-12

OPUS MAGNUM2 AND OPUS MAGNUM X KNOTLESS FIXATION DEVICES

Applicant Arthrocare Corp.

K number K083240

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MBI 2008-12-19

RIMCLOSE BONE ANCHOR

Applicant Anulex Technologies, Inc.

K number K082729

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MBI 2008-12-16

TOGGLELOC SYSTEM

Applicant Biomet Sports Medicine

K number K083070

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MBI 2008-10-17

TENODESIS CROSS SCREW, INTERFERENCE SCREW, SUTURE BEAD

Applicant TriMed, Inc.

K number K081348

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MBI 2008-08-26

2.0 PK SUTURE ANCHOR T, 2.0 PK SUTURE ANCHOR S

Applicant Smith & Nephew, Inc.

K number K081511

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MBI 2008-07-28

OPUS MAGNUM2 KNOTLESS FIXATION DEVICE (MODEL OM-1502), OPUS MAGNUM X KNOTLESS FIXATION DEVICE (MODEL OM-1503)

Applicant Arthrocare Corp.

K number K081497

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MBI 2008-07-03

SUTURE LOCK NAIL BONE ANCHOR WITH WHITE (KFX-W-200) & BLUE (KFX-B-200) FIBERFORCE SUTURE

Applicant Kfx Medical

K number K081598

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MBI 2008-06-13

SURGICRAFT SCREW FIXATION SYSTEM

Applicant Surgicraft , Ltd.

K number K080447

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MBI 2008-04-23

TORNIER CINCH KNOTLESS FIXATION IMPLANT SYSTEM

Applicant Tornier, Inc.

K number K080335

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MBI 2008-02-29

5.5 MM SUTURE LOCK BONE SCREW ANCHOR

Applicant Kfx Medical

K number K080229

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MBI 2008-01-07

THREVO ANCHOR, DISPOSABLE DRIVER, HI-FI SUTURES

Applicant Conmed Linvatec

K number K073481

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MBI 2007-12-07

CINCH KNOTLESS FIXATION IMPLANT SYSTEM

Applicant C2m Medical, Inc.

K number K073226

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MBI 2007-10-26

KFX TISSUE FIXATION SYSTEM AND ACCESSORIES

Applicant Kfx Medical

K number K072063

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MBI 2007-10-11

AXYA, MODEL 3000 AXYZLOOP TITANIUM BONE ANCHOR

Applicant Axya Medical, Inc.

K number K070773

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MBI 2007-09-17

SLEEVE AND BUTTON SOFT TISSUE DEVICES

Applicant Biomet Sports Medicine, Inc.

K number K071704

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MBI 2007-08-21

CONMED LINVATEC XO BUTTON

Applicant Conmed Linvatec

K number K070780

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MBI 2007-08-17

BIORAPTOR 2.3 PK SUTURE ANCHOR

Applicant Smith & Nephew Inc., Endoscopy Division

K number K071586

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MBI 2007-08-10

RENOVO SUTURE ANCHORS, MODELS 100-2001 THRU 100-5502X

Applicant Core Essence Orthopaedics, LLC

K number K071520

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MBI 2007-08-02

OPUS TWINLOCK KNOTLESS FIXATION DEVICE

Applicant Arthrocare Corp.

K number K071374

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MBI 2007-07-20

STRYKER PEEK TWINLOOP TAC

Applicant Stryker Endoscopy

K number K070882

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MBI 2007-07-02

ALLTHREAD PEEK ANCHOR WITH TANTALUM MARKER

Applicant Biomet, Inc.

K number K071569

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MBI 2007-05-16

SMITH & NEPHEW KINSA RC SUTURE ANCHOR

Applicant Smith & Nephew Inc., Endoscopy Division

K number K070908

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MBI 2007-05-16

STRYKER PEEK ZIP SUTURE ANCHOR

Applicant Stryker Endoscopy

K number K070758

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MBI 2007-04-16

OPUS MAGNUM PI KNOTLESS FIXATION DEVICE

Applicant Arthrocare Corp.

K number K070227

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MBI 2007-04-12

ENDOBUTTON DIRECT

Applicant Smith & Nephew Inc., Endoscopy Division

K number K070167

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MBI 2007-02-13

CINCH BONE ANCHOR SYSTEM

Applicant Sapphire Medical, Inc.

K number K062739

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MBI 2007-01-25

FEMORAL INTRAFIX SCREW AND SHEATH

Applicant Johnson & Johnson Company

K number K063577

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MBI 2006-12-19

MODIFICATION TO SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEM

Applicant Scandius Biomedical, Inc.

K number K063499

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MBI 2006-07-19

KFX KNOTLESS FIXATION SYSTEM

Applicant Kfx Medical

K number K061294

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MBI 2006-07-14

OPUS LABRALOCK P KNOTLESS FIXATION DEVICE

Applicant Arthrocare Corp.

K number K061349

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MBI 2006-06-08

KINSA SUTURE ANCHOR

Applicant Smith & Nephew, Inc.

K number K061154

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MBI 2006-02-03

EZLOC FEMORAL FIXATION DEVICE

Applicant Arthrotek, Inc.

K number K053461

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MBI 2005-12-20

SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEM

Applicant Scandius Biomedical, Inc.

K number K052810

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MBI 2005-12-05

ANSPACH KNOTLESS ANCHOR

Applicant The Anspach Effort, Inc.

K number K052572

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MBI 2005-10-07

AXYA MODEL 6500 AXYALOOP SELF-TAPPING BONE ANCHOR

Applicant Axya Medical, Inc.

K number K052491

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MBI 2005-06-29

NONRESORBABLE CENTRALOC TIBIAL SCREW & WASHER

Applicant Arthrotek, Inc.

K number K051069

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MBI 2005-03-02

THREVO SUTURE ANCHOR WITH DISPOSABLE DRIVER

Applicant Linvatec Corp.

K number K050227

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MBI 2004-11-12

OPUS MAGNUM KNOTLESS ANCHOR WITH INSERTER HANDLE

Applicant Opus Medical, Inc.

K number K042914

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MBI 2004-10-29

TI - SCREW ANCHOR SP

Applicant Arthrotek, Inc.

K number K042460

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MBI 2004-07-22

SUPER REVO HERCULINE SUTURE ANCHOR

Applicant Linvatec Corp.

K number K041713

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MBI 2004-06-25

OPUS MAGNUM ANCHOR WITH INSERTER

Applicant Opus Medical, Inc.

K number K041440

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MBI 2004-06-14

STRYKER WEDGE SUTURE ANCHOR SYSTEM

Applicant Stryker Endoscopy

K number K041310

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MBI 2004-06-07

FEMORAL HOOK

Applicant Arthrotek, Inc.

K number K041261

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MBI 2004-02-13

TITANIUM TOGGLE BUTTON(S)

Applicant Biomet Manufacturing, Inc.

K number K033838

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MBI 2003-05-05

ADHOC CLAW

Applicant Future Medical Systems, Inc.

K number K023963

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MBI 2002-11-25

ENDOTACK

Applicant KARL STORZ Endoscopy-America, Inc.

K number K022853

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MBI 2002-11-22

ULTRAFIX KNOTLESS MINIMITE SUTURE ANCHOR

Applicant Linvatec Corp.

K number K022827

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MBI 2002-10-04

AXYA MODEL 3000 AXYALOOP TITANIUM BONE ANCHOR SYSTEM

Applicant Axya Medical, Inc.

K number K022207

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MBI 2002-07-22

OPUS MAGNUM ANCHOR & INSTRUMENT SET

Applicant Opus Medical, Inc.

K number K020172

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MBI 2001-12-19

PRE-LOADED ULTRAFIX RC

Applicant Linvatec Corp.

K number K013553

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MBI 2001-12-13

ENDOFLIP

Applicant Arthocare Corporation

K number K013334

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MBI 2001-11-16

LACTOSORB CRANIOFACIAL ANCHOR-PUSH SCREW

Applicant Walter Lorenz Surgical, Inc.

K number K013557

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MBI 2001-10-22

METAL SCREW ANCHOR

Applicant Biomet Manufacturing, Inc.

K number K012503

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MBI 2001-08-31

MODEL 2000 AXYALOOP SELF-TAPPING BONE ANCHOR, MODEL 2000

Applicant Axya Medical, Inc.

K number K011912

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MBI 2001-06-12

TENODESIS SCREW, 5.5 MM, MODEL AR-1350-55

Applicant Arthrex, Inc.

K number K011007

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MBI 2001-06-06

BONUS-ORTHOPEDIC BONE SCREW FIXATION SYSTEM

Applicant Disc-O-Tech Medical Technologies, Ltd.

K number K011390

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MBI 2001-05-14

ARTHREX TWISTLOC SUTURE ANCHOR, MODEL AR-1924

Applicant Arthrex, Inc.

K number K010457

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MBI 2001-03-26

DJ ORTHOPEDICS FEMORAL ANCHOR

Applicant Dj Orthopedics, LLC

K number K002829

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MBI 2001-03-21

AXYA MEDICAL, INC. MODEL 1000 AXYALOOP BONE ANCHOR

Applicant Axya Medical, Inc.

K number K003971

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MBI 2001-03-21

DJ ORTHOPEDICS TIBIAL ANCHOR

Applicant Dj Orthopedics, LLC

K number K003960

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MBI 2001-02-23

FREEDLAND TENSION SYSTEM

Applicant Etzem Technologies, Inc.

K number K003648

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MBI 2001-02-09

STERILE BUTTON PLATE

Applicant Synthes (Usa)

K number K010121

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MBI 2000-11-15

LITWIN CRUICATE ANCHOR

Applicant Instrument Makar, Inc.

K number K002600

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MBI 2000-03-15

SYNTHES BUTTON PLATE

Applicant Synthes (Usa)

K number K994364

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MBI 2000-03-01

STAPLETAC2 BONE ANCHOR SYSTEM

Applicant American Medical Systems, Inc.

K number K000279

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MBI 2000-01-13

ACUMED SUTURE ANCHOR

Applicant Acu Med, Inc.

K number K993657

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MBI 1999-12-02

TALON ANCHOR SNAP-PAK

Applicant Mitek Products

K number K993261

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MBI 1999-10-14

RC MULTISUTURE BONE ANCHOR, MODEL 4453/4454

Applicant Innovasive Devices, Inc.

K number K992458

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MBI 1999-10-08

RC TACK

Applicant Innovasive Devices, Inc.

K number K992377

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MBI 1999-03-05

BONE ANCHOR SYSTEM III (BAS III)

Applicant Boston Scientific Corp

K number K990295

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MBI 1999-03-05

MULTITAK SS BUTTONS

Applicant Bonutti Research

K number K990156

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MBI 1999-02-16

MICROTAC-BONE ANCHOR SYSTEM

Applicant Influence, Inc.

K number K990160

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MBI 1999-02-01

STRAIGHT-IN-ORTHOPEDIC BONE SCREW FIXATION SYSTEM

Applicant Influence, Inc.

K number K990095

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MBI 1999-02-01

IMPLEX SCREW AND WASHER SYSTEM

Applicant Implex Corp.

K number K982751

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MBI 1999-01-28

INNOVASIVE DEVICES INTRATUNNEL TIBIAL FIXATION FASTENER

Applicant Innovasive Devices, Inc.

K number K983560

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MBI 1999-01-21

STABILIZER SOFT TISSUE ANCHOR, 5 AND 8MM; ANCHOR INSERTER, 5 AND 8MM; STABILIZER DRILL, 5 AND 8MM, NONSTERILE; STABILIZE

Applicant R. Thomas Grotz, M.D., Inc.

K number K984200

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MBI 1998-12-18

STRYKER WEDGE SUTURE ANCHOR

Applicant Stryker Endoscopy

K number K983557

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MBI 1998-12-16

POLYMER THREADED ANCHOR

Applicant Orthopaedic Biosystems, Ltd.

K number K983169

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MBI 1998-11-23

MITEK FASTIN RC ANCHOR

Applicant Mitek Products

K number K983818

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MBI 1998-10-13

INNOVASIVE TIBIAL FASTENER

Applicant Innovasive Devices, Inc.

K number K983056

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MBI 1998-09-22

KSEA FLIPPTACK

Applicant KARL STORZ Endoscopy-America, Inc.

K number K982571

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MBI 1998-09-14

SHERLOCK THREADED SUTURE ANCHOR (TIN COATED)

Applicant Doctor'S Research Group, Inc.

K number K982169

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MBI 1998-08-31

SHORT STRAIGHT-IN BONE SCREW FIXATION SYSTEM

Applicant Influence, Inc.

K number K982155

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MBI 1998-08-06

5.0MM PARACHUTE CORKSCREW SUTURE ANCHOR MODEL AR-22255, 3.5MM PARACHUTE CORKSCREW SUTURE ANCHOR MODEL AR-22235

Applicant Arthrex, Inc.

K number K974847

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MBI 1998-07-27

MENISCAL REPAIR DEVICE

Applicant Linvatec Corp.

K number K981692

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MBI 1998-07-17

WASHERLOC SCREW SYSTEM, LIGAMENT SCREW SYSTEM, NO-PROFILE BI-CORTICAL SCREW SYSTEM, CHANNEL LIGAMENT CLAMP, HECKMAN SCRE

Applicant Arthrotek/Biomet, Inc.

K number K981967

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MBI 1998-07-13

LM ANCHOR

Applicant Li Medical Technologies, Inc.

K number K981764

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MBI 1998-07-13

LM ANCHOR

Applicant Li Medical Technologies, Inc.

K number K981755

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MBI 1998-07-13

ANSPACH SUTURE ANCHOR

Applicant The Anspach Effort, Inc.

K number K981688

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MBI 1998-06-16

INNOVASIVE 3.5MM METAL ROC XS SUTURE BONE FASTENER

Applicant Innovasive Devices, Inc.

K number K981193

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MBI 1998-05-11

DEPUY ORTHOTECH CATERA SUTURE ANCHOR

Applicant DePuy Orthopaedics, Inc.

K number K980595

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MBI 1998-04-29

INNOVASIVE LINX TIBIAL LIGAMENT FASTENER

Applicant Innovasive Devices, Inc.

K number K980491

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MBI 1998-04-27

INNOVASIVE 10MM LINX HT LIGAMENT FASTENER

Applicant Innovasive Devices, Inc.

K number K980334

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MBI 1998-04-24

ACL CLIP-IN PLATE

Applicant Innovasive Devices, Inc.

K number K973874

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MBI 1998-04-16

HARPOON SUTURE ANCHORS

Applicant Biomet, Inc.

K number K973775

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MBI 1998-03-16

ACUMED SUTURE ANCHOR

Applicant Acu Med, Inc.

K number K980103

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MBI 1998-02-18

INNOVASIVE LINX BT 10MM LIGAMENT FASTENER

Applicant Innovasive Devices, Inc.

K number K974049

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MBI 1998-02-13

MITEK KNOTLESS ANCHOR

Applicant Mitek Products

K number K974345

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