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 1996-06-13

ALTA DOME AND PLUNGER (MEC HIP BOLT)

Applicant Howmedica Corp.

K number K961213

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KTT 1996-04-10

OMEGA+ COMPRESSION SCREW SYSTEM

Applicant Howmedica Corp.

K number K955306

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KTT 1996-03-18

PRACTIFIX EXTERNAL FIXATION SYSTEM

Applicant Orthopaedic Innovations, Inc.

K number K960014

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KTT 1996-01-26

VERSA-FX FEMORAL FIXATION SYSTEM

Applicant Zimmer, Inc.

K number K954555

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KTT 1995-10-31

INTRAMEDULLARY HIP SCREW (MODIFICATION)

Applicant Smith & Nephew Richards, Inc.

K number K954712

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KTT 1995-10-31

EBI X FIX DYNAFIX SYSTEM (DFS)

Applicant Electro-Biology, Inc.

K number K953406

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KTT 1995-07-13

GLIDING NAIL

Applicant Encore Orthopedics, Inc.

K number K951809

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KTT 1995-06-21

EBI SMALL EXTERNAL FIXATOR (S/E/F/)

Applicant Electro-Biology, Inc.

K number K951357

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KTT 1995-05-03

DEPUY COMPRESSION HIP SCREW SYSTEM

Applicant Depuy, Inc.

K number K946156

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KTT 1995-02-01

PEDIATRIC OSTEOTOMY SYSTEM

Applicant Howmedica Corp.

K number K945233

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KTT 1995-01-18

HOWMEDICA(R) MONO-TUBE(TM) EXTERNAL FIXATOR SYSTEM

Applicant Howmedica Corp.

K number K930836

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KTT 1994-11-28

GAMMA LOCKING NAIL - LONG LENGTH

Applicant Howmedica Corp.

K number K944883

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KTT 1994-09-28

ALPHATEC 130-150 SLOTTED COMPRESSION HIP SCREW

Applicant Alphatec Mfg., Inc.

K number K926417

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KTT 1994-03-14

GAMMA LOCKING NAIL MODIFICATION

Applicant Howmedica, Inc.

K number K940286

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KTT 1994-03-10

SYNTHES STERILE PINLESS EXTERNAL FIXATOR

Applicant Synthes (Usa)

K number K925460

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KTT 1994-03-07

GAMMA LOCKING NAIL-CROSS LOCKING SCREWS

Applicant Howmedica Corp.

K number K932174

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KTT 1994-02-22

MEGA PLUS SUPER LAG SCREW

Applicant Pfizer Hospital Products Group, Inc.

K number K930156

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KTT 1993-10-04

FIXEL EXTERNAL FIXATION DEVICE

Applicant Amp, Inc.

K number K923032

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KTT 1993-10-01

CAP WASHER ASSEMBLY

Applicant Howmedica Corp.

K number K915599

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KTT 1993-03-22

ALTA CANCELLOUS BONE SCREW

Applicant Howmedica Corp.

K number K925127

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KTT 1992-11-25

MORREY ELBOW FIXATOR

Applicant Howmedica Corp.

K number K910993

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KTT 1992-09-08

OMEGA PLUS COMPRESS HIP SCREW SYSTEM, MODIFICATION

Applicant Howmedica Corp.

K number K922295

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KTT 1992-07-17

INTRAMEDULLARY HIP SCREW

Applicant Smith & Nephew Richards, Inc.

K number K921786

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KTT 1992-07-14

MONOTUBE EXTERNAL FIXATION SYSTEM

Applicant Howmedica Corp.

K number K910483

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KTT 1992-06-19

AMERICA SYSTEM

Applicant I. Klimov Co.

K number K920608

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KTT 1992-01-21

RIHARDS TITANIUM HALF PIN

Applicant Smith & Nephew Richards, Inc.

K number K920024

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KTT 1992-01-16

TRAUMAFIX (TM) EXTERNAL FIXATOR

Applicant Synthes (Usa)

K number K914558

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KTT 1992-01-16

HOFFMANN DYNAMIC WRIST FIXATOR

Applicant Howmedica Corp.

K number K910986

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KTT 1991-08-14

INTRAMEDULLARY HIP SCREW, MODIFICATION

Applicant Smith & Nephew Richards, Inc.

K number K912162

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KTT 1991-05-29

PLATE BLADE WITH CURSOR OF L'UNION

Applicant Sport Service, Inc.

K number K911021

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KTT 1991-04-02

AUTOGENESIS(TM) AUTOMATOR

Applicant Advanced Biosearch Assn.

K number K905514

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KTT 1991-02-21

EXTERNAL FIXATION

Applicant Dynasplint Systems, Inc.

K number K904973

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KTT 1990-12-11

BLADE PLATE

Applicant O'Tec Corp.

K number K905352

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KTT 1990-12-11

JEWETT HIP NAIL

Applicant O'Tec Corp.

K number K905346

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KTT 1990-12-11

LAG SCREW

Applicant O'Tec Corp.

K number K905342

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KTT 1990-12-11

SIDE PLATE

Applicant O'Tec Corp.

K number K905338

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KTT 1990-10-04

KIRSCHNER BLADE PLATE SYSTEM OR R.A.B. BLADE PLATE

Applicant Kirschner Medical Corp.

K number K901234

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KTT 1990-07-30

JEWETT HIP NAIL

Applicant Onyx Medical Corp.

K number K903251

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KTT 1990-07-30

BLADE PLATE

Applicant Onyx Medical Corp.

K number K903250

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KTT 1990-07-30

SIDE PLATE

Applicant Onyx Medical Corp.

K number K903246

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KTT 1990-04-23

K-CAPE ORTHOPEDIC WIRES AND PINS

Applicant Westcon Orthopedics, Inc.

K number K901525

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KTT 1990-04-23

ORION BLADE PLATE FOR TIBIAL OSTEOTOMY

Applicant Med-Tek Corp.

K number K901272

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KTT 1990-04-18

ALTA LAG SCREW AND COMPRESSION SCREW

Applicant Howmedica Corp.

K number K900584

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KTT 1990-04-05

DR. HERZBERG DISPOSABLE EXTERNAL FIXATOR

Applicant Origin Medsystems, Inc.

K number K890989

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KTT 1990-03-13

LINK GIEBEL BLADE PLATE SYSTEM

Applicant Link America, Inc.

K number K895507

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KTT 1990-01-04

INTRAMEDULLARY HIP SCREW

Applicant Richards Medical Co., Inc.

K number K895241

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KTT 1989-08-28

DANEK WRIST FIXATOR

Applicant Danek Medical, Inc.

K number K891066

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KTT 1989-08-03

GAMMA LOCKING NAIL

Applicant Howmedica Corp.

K number K893639

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KTT 1989-06-13

DANEK RING FIXATOR (DRF)

Applicant Danek Medical, Inc.

K number K890814

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KTT 1988-09-22

AXIAL COMPRESSION SCREW

Applicant Straub Clinic and Hospital

K number K883715

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KTT 1988-09-22

TECHMEDICA MP SYSTEM

Applicant Techmedica, Inc.

K number K882922

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KTT 1987-10-28

ALTA SYSTEMS TIBIAL/UPPER EXTREMITY DIAPHYSEAL PLT

Applicant Howmedica Corp.

K number K873459

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KTT 1987-08-17

MODIFIED TROCHANTER CABLE GRIP SYSTEM

Applicant Howmedica Corp.

K number K872224

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KTT 1987-06-26

MODIFIED OMEGA COMPRESSION HIP SCREW SYSTEM

Applicant Howmedica Corp.

K number K872223

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KTT 1987-06-03

KRONNER COLLES-FOREARM EXTERNAL FIXATION

Applicant Kronner Medical

K number K871248

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KTT 1987-06-01

AXIAL COMPRESSION SCREW

Applicant Straub Clinic and Hospital

K number K870786

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KTT 1987-05-22

KRONNER BI-PLANER TIBIA EXTERNAL FIXATION

Applicant Kronner Medical

K number K871249

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KTT 1987-05-22

KRONNER UNIVERSAL FRAME EXTERNAL FIXATION

Applicant Kronner Medical

K number K871247

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KTT 1987-03-19

RICHARDS EXTERNAL FIXATION SYSTEM

Applicant Richards Medical Co., Inc.

K number K870961

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KTT 1986-09-15

SUPERFIXATION(TM)

Applicant Orthopaedic Device Corp.

K number K863343

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KTT 1986-07-25

SCREW DRIVER/BONE SCREW WRENCH/TAP & GUIDE PIN

Applicant Warsaw Orthopedic, Inc.

K number K862311

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KTT 1986-04-15

DEPUY COMPRESSION HIP SCREW SYSTEM

Applicant Depuy, Inc.

K number K861178

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KTT 1985-11-19

KIRSCHNER COMPRESSION HIP SCREW SYSTEM

Applicant Kirschner Medical Corp.

K number K854205

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KTT 1985-07-15

MEC ROD CONNECTOR

Applicant Pfizer, Inc.

K number K850443

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KTT 1985-07-15

MEC HIP BOLT

Applicant Pfizer, Inc.

K number K850413

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KTT 1985-07-15

MEC DISTAL FEMORAL BOLT

Applicant Pfizer, Inc.

K number K850403

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KTT 1985-06-28

SUPRACONDYLAR BONE PLATE

Applicant Warsaw Orthopedic, Inc.

K number K851919

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KTT 1985-06-21

TROCHANTER CABLE GRIP SYSTEM

Applicant Howmedica Corp.

K number K844068

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KTT 1984-10-22

AUTODYNAMIC COMPRESSION HIP SCREW-PLATE

Applicant Mecron Medical Products, Inc.

K number K843449

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KTT 1984-09-25

T.O.D. PLATE SYS STERILE

Applicant Kirschner Medical Corp.

K number K842695

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KTT 1984-09-25

T.O.D. PLATE SYSTEM

Applicant Kirschner Medical Corp.

K number K842681

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KTT 1984-09-21

ACE/FISHER EXTERNAL FIXATOR

Applicant Buckman Co., Inc.

K number K842768

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KTT 1983-03-25

CORSTREN COMPRESSION TUBE & PLATE

Applicant Zimmer, Inc.

K number K830196

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KTT 1982-12-28

COMPRESSION HIP SCREW SIDE-PLATE

Applicant Howmedica Corp.

K number K823548

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KTT 1982-01-12

ACE/KYLE CAPTURED HIP SCREW

Applicant Ace Orthopedic Manufacturing Co.

K number K813554

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KTT 1981-05-27

HUCKSTEP INTRAMEDULLARY NAIL

Applicant Downs Surgical , Ltd.

K number K811017

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KTT 1979-08-28

DYNAMIC HIP SCREW

Applicant Synthes (Usa)

K number K791619

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KTT 1979-04-10

PEDIATRIC OSTEOTOMY SYSTEM

Applicant Howmedica Corp.

K number K790501

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