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Staple, Fixation, Bone

FDA product code JDR · 215 cleared devices

Class 2 Orthopedic

Regulation: 21 CFR 888.3030
Review panel: OR
Implant: Yes
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1979-12-05 – 2026-09-01

JDR 2005-01-18

COMPRESSION STAPLE AND SIMPLE STAPLE

Applicant Wrightmedicaltechnologyinc

K number K043059

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JDR 2004-10-20

ARTHROTEK MENISCAL HYBRID DEVICE

Applicant Biomet, Inc.

K number K041988

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JDR 2004-05-28

PANALOK RC QUICKANCHOR PLUS, MODEL 212130, 212730; DUAL SUTURE PANALOK RC QUICKANCHOR PLLUS, MODELS 212132, 212732

Applicant Depuy Mitek

K number K041117

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JDR 2004-05-28

SUPER QUICKANCHOR PLUS

Applicant Depuy Mitek

K number K041116

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JDR 2004-05-28

GII QUICKANCHOR PLUS

Applicant Depuy Mitek, A Johnson & Johnson Company

K number K041115

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JDR 2004-05-13

BIOKNOTLESS RC ANCHOR

Applicant Depuy Mitek

K number K041064

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JDR 2004-05-07

PANALOK RC LOOP ANCHOR

Applicant Depuy Mitek

K number K041065

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JDR 2003-04-28

ORTHOPEDIC WIRE

Applicant Howmedica Osteonics Corp.

K number K031127

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JDR 2002-12-27

MITEK RAPIDLOC-PDS MENISCAL REPAIR SYSTEM

Applicant Mitek Worldwide

K number K023388

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JDR 2002-12-20

MITEK PDS/PGA STAPLE

Applicant Mitek Worldwide

K number K021953

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JDR 2002-11-07

SURETAC III, MODELS 7209900, 7209901

Applicant Smith & Nephew, Inc.

K number K023417

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JDR 2002-10-17

OSSTAPLE

Applicant Biomedical Ent., Inc.

K number K023203

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JDR 2002-10-09

SMITH & NEPHEW SURETAC - EXPANDED INDICATIONS II

Applicant Smith & Nephew, Inc.

K number K020948

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JDR 2001-10-01

DYNAMIC COMPRESSION SHAPE MEMORY ALLOY (SMA) STAPLE SYSTEM

Applicant Medtronic Sofamor Danek, Inc.

K number K012081

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JDR 2001-08-30

THE UNI-CLIP STAPLE

Applicant New Deal, S.A.

K number K011716

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JDR 2001-07-13

POLY-TAPES WITH THE FASTLOK FIXATION DEVICE

Applicant Xiros Plc

K number K010051

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JDR 2001-06-13

MEMODYN STAPLE

Applicant Telos Medical Equipment

K number K002695

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JDR 2001-05-30

SCAPHIX, STAPLE, FIXATION, BONE

Applicant Avanta Orthopaedics, Inc.

K number K003033

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JDR 2001-03-13

MEMOGRAPH; OSSTAPLE - ORTHOPEDIC USES FOR SMALL BONE AND FRAGMENT FIXATION FOR THE MEMOGRAPH STAPLE SYSTEM

Applicant Biomedical Ent., Inc.

K number K001354

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JDR 2000-04-03

OBL 2.0 MM MINI TAC ANCHOR, MODEL 10-1629-01

Applicant Orthopaedic Biosystems, Ltd.

K number K000797

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JDR 2000-02-25

MEMOGRAPH STAPLE, WARM SYSTEM

Applicant Biomedical Ent., Inc.

K number K993714

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JDR 2000-01-10

EIS DYNAMIC MEMORY STAPLES SYSTEM

Applicant Groupe Lepine

K number K991962

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JDR 1999-08-03

SOLUSTAPLE

Applicant New Deal, S.A.

K number K991566

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JDR 1999-06-03

UNI-CLIP STAPLE

Applicant New Deal, S.A.

K number K991482

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JDR 1999-03-04

POLYMER OBL SB ANCHOR / SUTURE COMBINATION

Applicant Orthopaedic Biosystems, Ltd.

K number K982996

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JDR 1998-08-24

MITEK MICRO ANCHOR

Applicant Mitek Products

K number K982420

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JDR 1998-07-13

LACTOSORB POP RIVET

Applicant Biomet, Inc.

K number K981798

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JDR 1997-08-05

MEMORY STAPLE (20 SIZES AVAILABLE)

Applicant Landos, Inc.

K number K964226

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JDR 1997-03-13

HOWMEDICA MAINSTAY ANCHOR

Applicant Howmedica Corp.

K number K965175

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JDR 1996-10-01

MITEK MICRO ANCHOR

Applicant Mitek Products

K number K962793

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JDR 1996-10-01

MLI MODULAR STAPLE

Applicant Medicinelodge, Inc.

K number K962705

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JDR 1996-07-10

SURGICAL DYNAMICS POP RIVET

Applicant United States Surgical, A Division of Tyco Healthc

K number K961585

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JDR 1996-07-10

SUTURE ANCHOR

Applicant United States Surgical, A Division of Tyco Healthc

K number K961578

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JDR 1996-07-10

ACUFEX TAG BIOABSORBABLE ANCHORS

Applicant Acufex Microsurgical, Inc.

K number K961555

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JDR 1996-01-31

LACTOSORB SUTURE ANCHOR

Applicant Poly-Medics,Inc.

K number K954443

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JDR 1996-01-18

PANALOK ABSORBABLE SUTURE ANCHOR SYSTEM

Applicant ETHICON, Inc.

K number K950272

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JDR 1995-10-05

ACUFEX TAG DELIVERY SYSTEM

Applicant Acufex Microsurgical, Inc.

K number K953276

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JDR 1995-09-26

HOWMEDICA MAINSTAY ANCHOR

Applicant Howmedica Corp.

K number K953531

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JDR 1995-08-25

LMT BONE ANCHOR

Applicant Li Medical Technologies, Inc.

K number K953764

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JDR 1995-08-25

SB ANCHOR

Applicant Orthopaedic Biosystems, Ltd.

K number K942889

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JDR 1995-08-21

OGDEN ANCHOR

Applicant American Medical Electronics, Inc.

K number K952348

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JDR 1995-08-07

CRADLE FIXATION DEVICE

Applicant Neoligaments, Ltd.

K number K941772

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JDR 1995-07-25

LACTOSORB POP RIVET

Applicant Poly-Medics,Inc.

K number K951658

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JDR 1995-05-30

ETHICON NONABSORBABLE SUTURE ANCHOR

Applicant ETHICON, Inc.

K number K943950

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JDR 1995-05-22

MITEK TOGGLE ANCHOR(TM)

Applicant Mitek Surgical Products, Inc.

K number K950070

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JDR 1995-04-26

ACUFEX TAG(R) BIOABSORBABLE ANCHORS

Applicant Acufex Microsurgical, Inc.

K number K946346

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JDR 1995-03-24

MITEK G III ANCHOR, MITEK LS ANCHOR

Applicant Mitek Surgical Products, Inc.

K number K944936

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JDR 1995-03-20

BIOABSORBABLE INTERFERENCE SCREW

Applicant Acufex Microsurgical, Inc.

K number K943548

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JDR 1995-03-06

MITEK THRADED ANCHOR (MTA)

Applicant Mitek Surgical Products, Inc.

K number K945203

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JDR 1995-02-09

OGDEN ANCHOR-SMALL (TENTATIVE)

Applicant American Medical Electronics, Inc.

K number K941029

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JDR 1995-02-09

ACUFEX TAG ANCHOR

Applicant Acufex Microsurgical, Inc.

K number K934867

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JDR 1995-02-01

ARTHREX STAPLES

Applicant Arthrex, Inc.

K number K943492

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JDR 1995-01-30

OGDEN ANCHOR ADDITIONAL APPLICATIONS

Applicant American Medical Electronics, Inc.

K number K935065

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JDR 1994-12-15

BONE ANCHOR

Applicant Acu Med, Inc.

K number K942787

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JDR 1994-10-19

INNOVASIVE SUTURE BONE FASTENER WITH SUTURE

Applicant Innovasive Devices, Inc.

K number K935321

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JDR 1994-08-12

XANCHOR SUTURE ATTACHMENT DEVICE

Applicant Orthopaedic Biosystems

K number K932041

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JDR 1994-07-22

MITEK GIII ANCHOR

Applicant Mitek Surgical Products, Inc.

K number K931782

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JDR 1994-07-12

OGDEN ANCHOR (MODIFICATION)

Applicant American Medical Electronics, Inc.

K number K935167

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JDR 1994-06-16

ACUFEX SURETAC

Applicant Acufex Microsurgical, Inc.

K number K931519

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JDR 1994-06-16

QUICKANCHOR II

Applicant Mitek Surgical Products, Inc.

K number K931253

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JDR 1994-04-26

BONE ANCHOR FOR SOFT TISSUE ATTACHMENT

Applicant Vesitec Medical, Inc.

K number K932925

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JDR 1994-03-07

BAUMER STAPLES

Applicant Baumer Ortopedia , Ltd.

K number K930967

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JDR 1994-01-07

MITEK MINI ANCHOR, MODIFICATION

Applicant Mitek Surgical Products, Inc.

K number K930892

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JDR 1993-12-08

MITEK SUPER QUICKANCHOR, MODIFICATION

Applicant Mitek Surgical Products, Inc.

K number K930893

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JDR 1993-11-16

STATAK & MINI-STATAK SOFT TISSUE ATTACHMENT DEVICE

Applicant Zimmer, Inc.

K number K926384

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JDR 1993-10-22

MITEK LIGAMENT ANCHOR

Applicant Mitek Surgical Products, Inc.

K number K926270

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JDR 1993-09-13

ACUFEX SURETAC(R) PAC

Applicant Acufex Microsurgical, Inc.

K number K930538

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JDR 1993-08-24

MINVASIVE SUTURE BONE FASTENER

Applicant Innovasive Devices, Inc.

K number K924034

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JDR 1993-07-26

OGDEN ANCHOR

Applicant Advanced Surgical Implants, Inc.

K number K924367

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JDR 1993-07-21

ACUFEX(R) TAG(TM)

Applicant Acufex Microsurgical, Inc.

K number K911293

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JDR 1993-06-09

VESITEC DRILL GUIDE

Applicant Vesitec Medical, Inc.

K number K931182

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JDR 1993-06-04

CONCEPT 4MM CANCELLOUS SCREW WITH EYELET

Applicant Linvatec Corp.

K number K924941

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JDR 1993-05-05

HARPOON SUTURE ANCHOR

Applicant Biomet, Inc.

K number K926037

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JDR 1992-10-27

QUICKANCHOR

Applicant Mitek Surgical Products, Inc.

K number K924665

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JDR 1992-10-22

MITEK BONE ANCHOR, MODIFICATION

Applicant Mitek Surgical Products, Inc.

K number K915889

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JDR 1992-06-09

QUICKANCHOR, MODIFICATION

Applicant Mitek Surgical Products, Inc.

K number K921873

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JDR 1992-05-01

MITEK ANCHOR, MITEK ANCHOR II

Applicant Mitek Surgical Products, Inc.

K number K920213

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JDR 1991-11-15

SURETAC POLYGLYCONATE ABSORBABLE FIXATION DEVICE

Applicant Acufex Microsurgical, Inc.

K number K911837

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JDR 1991-10-15

FASTLOK (STAPLE & BUCKLE) FIXATION SYSTEM

Applicant Neoligaments, Ltd.

K number K913461

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JDR 1991-06-28

FASTLOK (STAPLE AND BUCKLE) FIXATION SYSTEM

Applicant Neoligaments, Ltd.

K number K911445

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JDR 1991-05-29

THE TRAMOND PIN

Applicant Sport Service, Inc.

K number K911031

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JDR 1991-05-29

STAPLE BLADE FOR TIBIAL OSTEO/STAPLE BLADE L'UNION

Applicant Sport Service, Inc.

K number K911026

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JDR 1991-05-29

LIGAMENTOPLASTIC STAPLE OF L'UNION

Applicant Sport Service, Inc.

K number K911020

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JDR 1991-03-12

BIODEGRADABLE SURGICAL STAPLE

Applicant Instrument Makar, Inc.

K number K910723

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JDR 1991-01-04

SNAP-PAK (TM)

Applicant Mitek Surgical Products, Inc.

K number K905112

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JDR 1990-12-21

BONE STAPLE(S)

Applicant Synthes (Usa)

K number K904553

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JDR 1990-12-11

ROUND STAPLE

Applicant O'Tec Corp.

K number K905364

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JDR 1990-12-11

FIXATION STAPLE

Applicant O'Tec Corp.

K number K905363

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JDR 1990-12-11

BARBED SQUARE STAPLE

Applicant O'Tec Corp.

K number K905362

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JDR 1990-10-19

FASTLOK (STAPLE AND BUCKLE) FIXATION SYSTEM

Applicant Neoligaments, Ltd.

K number K904340

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JDR 1990-08-09

FIXATION STAPLE

Applicant Onyx Medical Corp.

K number K903022

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JDR 1990-07-30

BARBED SQUARE STAPLE

Applicant Onyx Medical Corp.

K number K903273

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JDR 1990-07-30

ROUND STAPLE

Applicant Onyx Medical Corp.

K number K903271

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JDR 1990-07-24

MITEK ANCHOR II

Applicant Mitek Surgical Products, Inc.

K number K902751

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JDR 1990-07-24

TENSTAPLE ORTHOPEDIC STAPLING SYSTEM

Applicant Tenstaple, Inc.

K number K896471

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JDR 1990-07-10

STAPLE, SERRATED, FIXATION W/SPIKES, VARIOUS SIZES

Applicant A. Henniss

K number K902567

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JDR 1990-05-09

HTO COMPRESSING STAPLE

Applicant Howmedica Corp.

K number K895117

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JDR 1990-04-04

MITEK ANCHOR(TM)

Applicant Mitek Surgical Products, Inc.

K number K897155

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JDR 1990-04-04

BONE SCREW

Applicant Karlin Technology, Inc.

K number K893203

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JDR 1989-09-19

MITEK ANCHOR

Applicant Mitek Surgical Products, Inc.

K number K892126

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