Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

FDA product code HWE · 75 cleared devices

Class 1 General, Plastic Surgery

Regulation: 21 CFR 878.4820
Review panel: OR
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1976-11-16 – 2011-01-20

HWE 2011-01-20

ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRES

Applicant Ortho Solutions Limited

K number K102743

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HWE 2007-01-16

SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBE

Applicant The Anspach Effort, Inc.

K number K063688

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HWE 2005-05-26

EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM

Applicant Zimmer Trabecular

K number K050766

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HWE 2005-01-05

SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM

Applicant Synthes (Usa)

K number K043310

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HWE 2002-09-18

REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS

Applicant Medical Device Services

K number K022744

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HWE 2002-02-04

REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS

Applicant Adven Medical

K number K012694

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HWE 2002-02-04

REPROCESSED USED, DISPOSABLE BLADES, BURS, BITS AND TAPS

Applicant Adven Medical

K number K012676

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HWE 1999-09-24

AVCORE SYSTEM

Applicant Modular Cutting Systems, Inc.

K number K990816

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HWE 1997-12-29

AESCULAP HILAN MOTOR SYSTEM

Applicant Aesculap, Inc.

K number K973736

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HWE 1997-11-12

BONE GRAFT HARVESTER

Applicant Ds Mfg., Inc.

K number K973560

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HWE 1997-08-26

SURGICAL BURS AND SURGICAL DRILL BITS

Applicant Synvasive Technology, Inc.

K number K972508

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HWE 1997-07-08

DISK WHISK CUTTING DEVICE (CONICAL, ELLIPTICAL AND BALL HEAD)

Applicant Disk Whisk, Inc.

K number K971342

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HWE 1997-05-28

SYNTHES (USA) COMPACT AIR DRIVE II (CAD II)

Applicant Synthes (Usa)

K number K971544

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HWE 1997-04-23

SERVOTRONIC EC100 SYSTEM

Applicant Medicon, Inc.

K number K962087

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HWE 1997-04-07

RIWO DRIVE WITH FOOTSWITCH/MOTOR HANDLE, COOMPLETE,6000RPM/3000RPM/ROTARY BLADES AND ABRADERS SEE SECTION 1:

Applicant Richard Wolf Medical Instruments Corp.

K number K970088

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HWE 1997-02-28

SPINE-TECH BONE HARVESTER

Applicant Spine-Tech, Inc.

K number K970040

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HWE 1997-02-28

MEDNEXT SURGICAL BUR

Applicant Mednext, Inc.

K number K970023

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HWE 1996-11-14

SYNTHES STERILE DRILL BITS

Applicant Synthes (Usa)

K number K962913

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HWE 1996-09-11

STRYKER UNIVERSAL DRILL ATTACHMENTS & ACCESSORIES

Applicant Stryker Instruments

K number K962800

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HWE 1996-08-15

CONSENSUS POSTERIOR STABILIZED KNEE-INTERCONDYLAR NOTCH ROUTER

Applicant U.S. Medical Products, Inc.

K number K962215

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HWE 1996-08-05

POWERCUT GOLD SURGICAL SYSTEM

Applicant Baxter Healthcare Corp

K number K962022

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HWE 1996-07-26

COMMAND 2 MICOELECTRIC SURGICAL SYSTEM

Applicant Stryker Corp.

K number K961970

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HWE 1996-06-13

CEMENT AND BONE REMOVAL KIT

Applicant Maillefer Instruments S.A.

K number K961759

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HWE 1996-04-23

EXACTECH STERILE MODULAR DRILL BIT

Applicant Exactech, Inc.

K number K960720

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HWE 1996-03-20

HALL MODULAR ACETABULAR REAMER SYSTEM

Applicant Linvatec Corp.

K number K960852

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HWE 1996-02-05

AESCULAP POWER SYSTEMS (ELAN-E & MICROTRON)

Applicant Aesculap, Inc.

K number K953968

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HWE 1996-01-22

3M MINI-DRIVER ELECTRIC SYSTEM

Applicant 3M Company

K number K955098

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HWE 1996-01-18

MICROAIRE SMARTDRIVE SYSTEM

Applicant Microaire Surgical Instruments, Inc.

K number K955591

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HWE 1995-06-22

GRAFTOLOGER PGH & ACL RECONSTRUCTION INSTRUMENT SET

Applicant Neoligaments, Ltd.

K number K952543

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HWE 1995-05-05

CONSENSUS(TM) ORTHOPEDIC DRILL BIT

Applicant U.S. Medical Products, Inc.

K number K950013

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HWE 1995-04-05

CONSENSUS(TM) PATELLA REAMER

Applicant U.S. Medical Products, Inc.

K number K946197

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HWE 1995-02-01

CONSENUS HIP SYSTEM FEMORAL CANAL STARTER REAMER

Applicant U.S. Medical Products, Inc.

K number K944946

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HWE 1995-01-27

CONSENSUS HIP SYSTEM -- TROCHANTERIC CUTTER

Applicant U.S. Medical Products, Inc.

K number K945208

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HWE 1995-01-27

CONSENSUS HIP SYSTEM -- CALCAR PLANER

Applicant U.S. Medical Products, Inc.

K number K945189

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HWE 1995-01-27

CONSENUS HIP SYSTEM -- ACETABULAR REAMER

Applicant U.S. Medical Products, Inc.

K number K945186

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HWE 1994-12-15

STRYKER TOTAL PERFORMANCE SYSTEM

Applicant Stryker Corp.

K number K943589

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HWE 1994-10-11

COHORT BONE BRUSH

Applicant Advanced Med/Surg, Inc.

K number K942108

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HWE 1994-09-23

SURGICAL INSTRUMENTS AND ACCESSORIES

Applicant Stryker Corp.

K number K942956

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HWE 1994-09-07

HALL MICROCHOICE ELECTRIC POWERED SYSTEM

Applicant Hall Surgical, Division of Zimmer, Inc.

K number K942660

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HWE 1994-09-01

TOTAL KNEE KIT

Applicant Biodynamic Technologies, Inc.

K number K932918

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HWE 1994-04-29

COOL CUT

Applicant Mitab

K number K931429

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HWE 1994-04-25

THE GRAFTOLOGER

Applicant Neoligaments, Ltd.

K number K935753

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HWE 1994-02-22

INTERMEDICS ORTHOPEDICS DRILL BITS

Applicant Intermedics Orthopedics

K number K931734

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HWE 1994-01-28

SNAP BONE REAMER

Applicant Surgiquip, Inc.

K number K935322

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HWE 1994-01-27

SNAP DRILL

Applicant Surgiquip, Inc.

K number K935516

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HWE 1994-01-26

BONE SAW BLADES

Applicant Betzler Mfg., Inc.

K number K931176

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HWE 1994-01-25

ARTHREX AR-8200 SHAVER SYSTEM

Applicant Arthrex, Inc.

K number K932699

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HWE 1994-01-21

SODEM POWER SYSTEM

Applicant Sodemsystems

K number K935567

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HWE 1994-01-07

ES-100 ACCESSORIES

Applicant Elekta Instruments, Inc.

K number K932261

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HWE 1994-01-07

ACUFEX STERILE DRILLS

Applicant Acufex Microsurgical, Inc.

K number K931837

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HWE 1994-01-07

POWERED SURGICAL INSTRUMENT ACCESSORY

Applicant Intenn Engineering, Inc.

K number K930363

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HWE 1994-01-07

OSTEON ADAPTOR/CRADLE

Applicant United American Medical Co., Inc.

K number K930319

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HWE 1992-09-18

HHI ELECTRIC CONSOLE #875-000

Applicant H&H Instruments

K number K922056

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HWE 1992-06-08

CKS OSCILLATING SAW BLADE

Applicant Techmedica, Inc.

K number K921131

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HWE 1991-07-02

STERILE PACKAGED POWER INSTRUMENT ACCESSORIES

Applicant United American Medical Co., Inc.

K number K911930

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HWE 1991-07-02

SMALL BONE FIXATION SYSTEM

Applicant United American Medical Co., Inc.

K number K911929

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HWE 1990-11-26

ACE/WILLIAMS MICROSURGERY SAW SYSTEM

Applicant Buckman Co., Inc.

K number K902525

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HWE 1990-09-14

OSCILLATING SAW BLADES # SO-305,MO-305 AND ZO-305

Applicant Micro-Aire Surgical Instruments, Inc.

K number K903650

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HWE 1990-08-14

CORING NEEDLE (TREPHINE, ORTHOPEDIC)

Applicant Biomedtrix, Ltd.

K number K902447

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HWE 1990-06-25

HALL MODULAR ACETABULAR REAMER SYSTEM

Applicant Zimmer, Inc.

K number K902332

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HWE 1990-06-13

MODULAR FLEXIBLE DRILLING SYSTEM

Applicant Dalton Technology, Inc.

K number K901165

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HWE 1989-09-15

HALL VERSIPOWER SURGICAL INSTRUMENT SYSTEM

Applicant Zimmer, Inc.

K number K895198

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HWE 1988-06-10

ACE SCREW REMOVAL TREPHINE

Applicant Buckman Co., Inc.

K number K882008

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HWE 1988-03-04

PACESETTER (TM) 3500 ARTHROSCOPIC SURGICAL SYSTEM

Applicant Dyonics, Inc.

K number K880150

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HWE 1987-10-15

INTRA-ARTICULAR ARTHROSCOPIC SHAVER

Applicant Medline Industries, Inc.

K number K874044

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HWE 1987-06-05

MODEL 28200C MICRO-ARTHROPLASTY SYSTEM

Applicant KARL STORZ Endoscopy-America, Inc.

K number K871717

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HWE 1987-01-28

HALL (R) MICRO E POWERED SURGICAL INSTRUMENT SYST

Applicant Hall Surgical, Division of Zimmer, Inc.

K number K864929

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HWE 1986-03-04

3M ARTHROSCOPIC SURGICAL SYSTEM

Applicant 3M Company

K number K855216

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HWE 1986-02-11

INTRA-ARTICULATED ARTHROSCOPIC POWER SYSTEM

Applicant Richard Wolf Medical Instruments Corp.

K number K854987

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HWE 1985-11-13

MORGAN SUTURE-DRILL

Applicant Bowen & Company, Inc.

K number K853376

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HWE 1985-09-30

DEXTRA PRECISION POWER SYSTEM

Applicant Chattanooga Group, Inc.

K number K853489

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HWE 1983-12-28

TORQUE PLUS CATALOG 30120

Applicant Concept, Inc.

K number K833940

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HWE 1980-09-16

C-BLADE

Applicant Cutter Laboratories, Inc.

K number K802105

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HWE 1979-12-27

INTRA-ARTICULATED EDGER-PLANER SYSTEM

Applicant Richard Wolf Medical Instruments Corp.

K number K792353

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HWE 1976-11-16

CHARNLEY FEMUR DRILL #1 AND #2

Applicant Codman & Shurtleff, Inc.

K number K760977

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