Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

FDA product code KTT · 378 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: 1979-04-10 – 2026-06-11

KTT 2004-04-30

VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES

Applicant Vanguard Medical Concepts, Inc.

K number K031687

View details →

KTT 2004-04-29

MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM

Applicant Ebi, L.P.

K number K040833

View details →

KTT 2004-03-23

SYNTHES MEDIUM EXTERNAL FIXATION SYSTEM-MR SAFE

Applicant Synthes (Usa)

K number K040258

View details →

KTT 2004-03-23

NEWMEDICAL MICRO BONE DISTRACTOR/FIXATOR

Applicant Newmedical Technology, Inc.

K number K040064

View details →

KTT 2004-03-01

3.5 MM LCP DISTAL HUMERUS SYSTEM

Applicant Synthes (Usa)

K number K033995

View details →

KTT 2004-01-20

MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM

Applicant Howmedica Osteonics Corp.

K number K033476

View details →

KTT 2004-01-13

SYNTHES (USA) LCP DYNAMIC HELICAL HIP SYSTEM

Applicant Synthes (Usa)

K number K033556

View details →

KTT 2003-12-18

MODIFICATION TO SLIM GLIDING NAIL SYSTEM

Applicant Plus Orthopedics

K number K033763

View details →

KTT 2003-12-03

MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM

Applicant Ebi, L.P.

K number K033635

View details →

KTT 2003-11-26

SYNTHES (USA) STERILE ADJUSTABLE DISTAL RADIUS FIXATOR (ADRF) WITH 4.0MM/3.0MM SELF-DRILLING SCHANZ SCREWS

Applicant Synthes (Usa)

K number K033411

View details →

KTT 2003-11-05

SYNTHES REPROCESSED EXTERNAL FIXATION DEVICES

Applicant Synthes (Usa)

K number K033158

View details →

KTT 2003-11-05

WRISTJACK ORIF SYSTEM, WRISTJACK ORIF SYSTEM, NON-STERILE, MODELS CFD-347, CFD-347-NS

Applicant Hand Biomechanics Lab, Inc.

K number K033112

View details →

KTT 2003-10-22

INTER-OS LIMB LENGTHENER

Applicant Inter-Os Technologies

K number K031875

View details →

KTT 2003-09-04

EBI XFIX DFS SYSTEM

Applicant Ebi, L.P.

K number K031919

View details →

KTT 2003-08-06

FIXION DYNAMIC HIP SCREW SYSTEM (FIXION DHS)

Applicant Disco-O-Tech Medical Technologies, Ltd.

K number K031401

View details →

KTT 2003-07-30

MODIFICATION TO REPROCESSED SYNTHES EXTERNAL FIXATION DEVICES

Applicant Alliance Medical Corp.

K number K032058

View details →

KTT 2003-07-14

SYNTHES SMALL COBINATION CLAMP-MR SAFE

Applicant Synthes (Usa)

K number K031724

View details →

KTT 2003-07-14

EXTERNAL FIXATION SYSTEMS

Applicant Smith & Nephew, Inc.

K number K031181

View details →

KTT 2003-07-10

EBI XFIX OPTIROM KNEE FIXATOR

Applicant Ebi, L.P.

K number K031093

View details →

KTT 2003-06-25

EBI XFIX DFS SYSTEM

Applicant Ebi, L.P.

K number K031645

View details →

KTT 2003-06-24

SYNTHES TI-15 MO LOCKING DISTAL RADIUS PLATING SYSTEM

Applicant Synthes (Usa)

K number K031725

View details →

KTT 2003-06-06

SYNTHES 3.5 MM LOW PROFILE PELVIC RECONSTRUCTION PLATE

Applicant Synthes (Usa)

K number K031573

View details →

KTT 2003-03-06

MODIFICATION TO EBI DYNAFIX DIAPHYSEAL CORRECTION SYSTEM

Applicant Ebi, L.P.

K number K030372

View details →

KTT 2003-02-03

REPROCESSED EXTERNAL FIXATION DEVICE

Applicant Alliance Medical Corp.

K number K023714

View details →

KTT 2003-01-28

PRECIMED HIP SCREW SYSTEM

Applicant Precimed, Inc.

K number K023851

View details →

KTT 2003-01-23

SYNTHES TOMOFIX OSTEOTOMY SYSTEM

Applicant Synthes (Usa)

K number K023941

View details →

KTT 2003-01-22

MODIFICATION TO EBI XFIX DFS SYSTEM METAPHYSEAL CORRECTION SYSTEM

Applicant Ebi, L.P.

K number K024248

View details →

KTT 2003-01-15

MODIFICATION TO EBI XFIX DFS SYSTEM

Applicant Ebi, L.P.

K number K024129

View details →

KTT 2002-10-25

EBI XFIX DFS SYSTEM

Applicant Ebi, L.P.

K number K023399

View details →

KTT 2002-10-18

MODIFICATION TO EBI XFIX DFS SYSTEM

Applicant Ebi, L.P.

K number K023324

View details →

KTT 2002-10-18

MICROFIX

Applicant Fixano SA

K number K023314

View details →

KTT 2002-09-23

TWIN FIX

Applicant Fixano SA

K number K022771

View details →

KTT 2002-09-17

EXTERNAL FIXATION RING

Applicant Rigid FX Orthopedics, Incorporated

K number K022423

View details →

KTT 2002-08-26

TEMPFIX EXTERNAL FIXATION SYSTEM

Applicant DePuy Orthopaedics, Inc.

K number K021933

View details →

KTT 2002-08-12

EBI XFIX DFS SYSTEM

Applicant Ebi, L.P.

K number K022319

View details →

KTT 2002-06-24

REPROCESSED HOWMEDICA EXTERNAL FIXATION DEVICES

Applicant Alliance Medical Corp.

K number K012648

View details →

KTT 2002-06-24

REPROCESSED EXTERNAL FIXATION DEVICE

Applicant Alliance Medical Corp.

K number K012623

View details →

KTT 2002-06-20

EBI DYNAFIX DIAPHYSEAL CORRECTION SYSTEM

Applicant Ebi, L.P.

K number K021695

View details →

KTT 2002-06-05

OMEGA II SYSTEM

Applicant Howmedica Osteonics Corp.

K number K020772

View details →

KTT 2002-05-23

EBI DFS OPTIROM ELBOW FIXATOR

Applicant Ebi, L.P.

K number K021312

View details →

KTT 2002-05-16

EBI XFIX RAIL SYSTEM

Applicant Ebi, L.P.

K number K021031

View details →

KTT 2002-05-03

EBI XFIX DFS SYSTEM

Applicant Ebi, L.P.

K number K021091

View details →

KTT 2002-04-29

CLEARVIEW WRIST FIXATOR

Applicant Rigid FX Orthopedics, Incorporated

K number K020311

View details →

KTT 2002-03-08

MODIFICATION TO EBI XFIX DFS OPTIROM ELBOW FIXATOR

Applicant Ebi, L.P.

K number K020403

View details →

KTT 2002-03-04

WRISTORE FIXATOR

Applicant Millennium Medical Technologies, Inc.

K number K012294

View details →

KTT 2002-03-01

MODIFICATION TO EBI XFIX DFS SYSTEM

Applicant Ebi, L.P.

K number K014276

View details →

KTT 2002-02-22

SLIM GLIDING NAIL SYSTEM

Applicant Plus Orthopedics

K number K020240

View details →

KTT 2002-02-05

MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM

Applicant Ebi, L.P.

K number K020141

View details →

KTT 2002-01-17

MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM

Applicant Ebi, L.P.

K number K014194

View details →

KTT 2001-11-20

EBI XFIX ACCESS PELVIC FIXATOR

Applicant Ebi, L.P.

K number K013540

View details →

KTT 2001-11-16

MODIFICATION TO: STERILE COLLES CLASSIC FIXATOR

Applicant DePuy Orthopaedics, Inc.

K number K013503

View details →

KTT 2001-11-08

EBI XFIX DFS SYSTEM

Applicant Ebi, L.P.

K number K013378

View details →

KTT 2001-09-27

RADIOFIX

Applicant Fixano SA

K number K012078

View details →

KTT 2001-09-27

PF2

Applicant Fixano SA

K number K012062

View details →

KTT 2001-08-15

VHS PEDIATRIC HIP SCREW SYSTEM

Applicant Walter Abendschein, M.D.

K number K011603

View details →

KTT 2001-07-25

EBI XFIX DFS SYSTEM

Applicant Ebi, L.P.

K number K012024

View details →

KTT 2001-06-29

MODIFICATION TO EBI EFIX VISION FIXATION SYSTEM

Applicant Ebi, L.P.

K number K011711

View details →

KTT 2001-06-27

EBI XFIX ACCESS PELVIC FIXATOR

Applicant Ebi, L.P.

K number K011697

View details →

KTT 2001-06-27

SYNTHES (USA) MEDIUM EXTERNAL FIXATION SYSTEM

Applicant Synthes (Usa)

K number K011034

View details →

KTT 2001-06-12

SYNTHES (USA) LARGE FRAGMENT LOCKING COMPRESSION PLATE (LCP) SYSTEM-T PLATE

Applicant Synthes (Usa)

K number K010766

View details →

KTT 2001-05-23

SYNTHES ANTEROLATERAL CALCANEAL PLATE

Applicant Synthes (Usa)

K number K010518

View details →

KTT 2001-05-03

ADJUSTABLE LARGE FIXATOR SYSTEM

Applicant Synthes (Usa)

K number K010344

View details →

KTT 2001-03-13

MODIFICATION TO EBI XFIX DFS RAIL SYSTEM

Applicant Ebi, L.P.

K number K010437

View details →

KTT 2001-01-29

COLLES C SERIES FRAME STERILE PACK

Applicant DePuy Orthopaedics, Inc.

K number K003397

View details →

KTT 2000-05-23

EBI XFIX DFS METAPHYSEAL CORRECTION SYSTEM

Applicant Ebi, L.P.

K number K001358

View details →

KTT 2000-05-05

PIONEER SURGICAL TECHNOLOGY EXTENDED GTR, MODEL 501-601

Applicant Pioneer Surgical Technology

K number K000734

View details →

KTT 2000-05-01

SYNTHES LARGE FRAGMENT DYNAMIC COMPRESSION LOCKING (DCL) SYSTEM

Applicant Synthes (Usa)

K number K000682

View details →

KTT 2000-04-28

SMALL FRAGMENT DYNAMIC COMPRESSION LOCKING (DCL) SYSTEM

Applicant Synthes (Usa)

K number K000684

View details →

KTT 2000-02-25

EBI XFIX DFS SYSTEM

Applicant Ebi, L.P.

K number K000319

View details →

KTT 2000-02-03

EBI XFIX DFS RAIL SYSTEM

Applicant Ebi, L.P.

K number K000083

View details →

KTT 2000-01-03

ALPHATEC EXTERNAL FIXATION SYSTEM COMPRESSION/DISTRACTION ROD

Applicant Alphatec Mfg., Inc.

K number K993873

View details →

KTT 1999-12-20

SMITH & NEPHEW COMPRESSION HIP SCREW SYSTEM, INTRAMEDULLARY HIP SCREW SYSTEM

Applicant Smith & Nephew, Inc.

K number K993289

View details →

KTT 1999-12-14

EBI XFIX VISION FIXATION SYSTEM

Applicant Ebi, L.P.

K number K993886

View details →

KTT 1999-11-19

EBI XFIX DFS WRISTFIX SYSTEM

Applicant Ebi, L.P.

K number K993649

View details →

KTT 1999-08-19

EBI XFIX DFS RAIL SYSTEM

Applicant Electro-Biology, Inc.

K number K991941

View details →

KTT 1999-08-17

EBI XFIX DFS OPTIROM ELBOW FIXATOR

Applicant Ebi, L.P.

K number K992515

View details →

KTT 1999-08-06

VHS SUPRACONDYLAR PLATE SYSTEM

Applicant Walter Abendschein, M.D.

K number K991806

View details →

KTT 1999-03-02

SYNTEC-TAICHUNG NON-STERILE SMALL ORTHOPEDIC FIXATION SYSTEM, MODEL 71100, 294-300,400 & 292-730/820

Applicant Syntec Scientific Corp.

K number K984364

View details →

KTT 1999-02-18

SYNTHES (USA) ARTICULATING DISTAL RADIUS (ADRF) SYSTEM

Applicant Synthes (Usa)

K number K984498

View details →

KTT 1998-12-30

SYNTEC-TAICHUNG NON-STERILE DHS/DCS PLATE SYSTEM

Applicant Syntec Scientific Corp.

K number K983873

View details →

KTT 1998-07-08

EBI DFS JOINT FIXATOR, MODEL 02800

Applicant Electro-Biology, Inc.

K number K981483

View details →

KTT 1998-04-14

BIOSYMMETRIC PROXIMAL INTERPHALANGEAL JOINT FIXATOR

Applicant Biomet, Inc.

K number K980370

View details →

KTT 1998-02-19

FRIEDL GLIDING NAIL SYSTEM

Applicant Plus Orthopedics

K number K974409

View details →

KTT 1998-02-18

SYNTHES CANNULATED ANGLE BLADE PLATE (CABP) SYSTEM

Applicant Synthes (Usa)

K number K974537

View details →

KTT 1997-11-20

HOFFMANN II COMPACT PERIARTICULAR CLAMP

Applicant Howmedica, Inc.

K number K973321

View details →

KTT 1997-11-20

THE CORIFIX DYNAMIC HIP SCREW SYSTEM

Applicant Corin USA

K number K973231

View details →

KTT 1997-11-12

ODI COMPRESSION HIP SCREW SYSTEM

Applicant Orthopaedic Designs, Inc.

K number K971993

View details →

KTT 1997-10-16

SYNTHES COMBINATION CLAMP AND DYNAMIZATION CLIP

Applicant Synthes (Usa)

K number K973017

View details →

KTT 1997-10-16

VARI-ANGLE HIP SCREW (VHS) SYSTEM

Applicant Walter Abendschein, M.D.

K number K964880

View details →

KTT 1997-10-09

DEPUY AE TK2 HIP SCREW SYSTEM

Applicant Depuy, Inc.

K number K972629

View details →

KTT 1997-05-09

TAYLOR SPATIAL FRAME EXTERNAL FIXATION SYSTEM

Applicant Smith & Nephew, Inc., Orthopaedic Div.

K number K970748

View details →

KTT 1997-04-28

ALPHATEC EXTERNAL FIXATION SYSTEM

Applicant Alphatec Mfg., Inc.

K number K964400

View details →

KTT 1997-04-01

EBI X FIX DYNAFIX MINI EXTERNAL FIXATION SYSTEM

Applicant Ebi, L.P.

K number K970290

View details →

KTT 1997-01-22

MEDOFF SLIDING PLATE (PROPOSED NAME)

Applicant Wrightmedicaltechnologyinc

K number K962251

View details →

KTT 1996-12-09

ELLIS EXTERNAL MINI-FIXATOR SYSTEM

Applicant Link America, Inc.

K number K964458

View details →

KTT 1996-11-27

MINIFIX

Applicant Ferguson Medical

K number K964094

View details →

KTT 1996-09-05

SYNTHES TITANIUM EXTERNAL FIXATOR CLAMPS (TI EFC)

Applicant Synthes (Usa)

K number K962484

View details →

KTT 1996-08-19

ILIZAROV EXTERNAL FIXATION SYSTEM

Applicant Smith & Nephew Richards, Inc.

K number K962808

View details →

KTT 1996-06-28

EBI X FIX DYNAFIX SYSTEM/EBI DFS DISTAL RADIUS FIXATOR SC BONE SCREWS

Applicant Electro-Biology, Inc.

K number K961433

View details →

KTT 1996-06-28

SYNTHES MINI EXTERNAL FIXATOR

Applicant Synthes (Usa)

K number K961350

View details →