Orthopedic Manual Surgical Instrument

FDA product code LXH · 57 cleared devices

Class 1 Orthopedic

Regulation: 21 CFR 888.4540
Review panel: OR
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1980-02-22 – 2019-12-20

LXH 2019-12-20

SX-One MicroKnife

Applicant Sonex Health, Inc.

K number K192873

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LXH 2010-12-09

SELF RETAINING SOFT TISSUE RETRACTOR

Applicant Koros USA, Inc.

K number K101609

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LXH 2000-06-14

MICROPERFORATION INSTRUMENT

Applicant Smith & Nephew, Inc.

K number K001507

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LXH 1996-01-22

ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEM

Applicant Orthopedic Systems, Inc.

K number K952495

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LXH 1995-04-26

ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SY

Applicant Orthomet, Inc.

K number K943873

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LXH 1995-04-13

SPINAL MARKER

Applicant Leibinger L.P.

K number K944188

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LXH 1994-11-07

STEADMAN LIGAMENT GRAFT PASSER AND PROTECTOR

Applicant Depuy, Inc.

K number K941896

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LXH 1994-08-26

HYPERFLEX FLEXIBLE GUIDEWIRES

Applicant Linvatec Corp.

K number K941711

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LXH 1994-08-05

STRYKER FEMORAL CANAL BRUSH, ACETABULAR BRUSH

Applicant Stryker Corp.

K number K941605

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LXH 1994-02-01

PUNCH SURGICAL

Applicant Mahe-Medizintechnik

K number K933772

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LXH 1994-01-28

SOFAMOR ORTHOPAEDIC INSTRUMENTS

Applicant Danek Medical, Inc.

K number K933242

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LXH 1994-01-26

BARRIER BONE WAX APPLICATOR

Applicant Phillips Pharmaceuticals, Inc.

K number K934260

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LXH 1994-01-21

BIO-PREP

Applicant Biomedical Devices, Inc.

K number K931846

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LXH 1993-02-16

CALMPS: BONE, MASTIN, LEWIN, BRAND

Applicant Thomasville Medical Assoc.

K number K930028

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LXH 1992-06-04

SURGICAL INSTRUMENT, DISPOSABLE

Applicant Macro Medical, Inc.

K number K921402

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LXH 1992-06-03

AMSEN SPINE IMPACTOR INSTRUMENTS

Applicant Advanced Med/Surg, Inc.

K number K921645

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LXH 1992-06-03

AMSEN HOCKEY STICK CHISEL

Applicant Advanced Med/Surg, Inc.

K number K921644

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LXH 1992-06-03

AMSEN POSTERIOR DISC EVACUATOR

Applicant Advanced Med/Surg, Inc.

K number K921643

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LXH 1992-06-03

AMSEN DOUBLE-ENDED FORAMINAL PROBE

Applicant Advanced Med/Surg, Inc.

K number K921642

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LXH 1990-09-28

OSTEOTOMES OF VARIOUS TYPES

Applicant Mumtaz I. Malik

K number K901521

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LXH 1990-09-28

CHISEL, BONE, SURGICAL

Applicant Mumtaz I. Malik

K number K901511

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LXH 1990-09-28

VOLKMAN BONE CURRETTE 5, 5-3/4, 6-3/4, 8

Applicant Mumtaz I. Malik

K number K901420

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LXH 1990-09-28

RONGEUR, ORTHOPEDIC SURGICAL INSTRUMENTS

Applicant Mumtaz I. Malik

K number K901289

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LXH 1990-08-09

LAMINECTOMY ROGEUR

Applicant Ruggles Corp.

K number K902819

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LXH 1990-07-30

T-HANDLE HEX WRENCH

Applicant Onyx Medical Corp.

K number K903270

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LXH 1990-07-30

DRIVER/EXTRACTOR

Applicant Onyx Medical Corp.

K number K903257

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LXH 1990-07-30

ADJUSTABLE ANGLE GUIDE

Applicant Onyx Medical Corp.

K number K903247

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LXH 1989-09-12

KRONNER SACRAL PIN GUIDE

Applicant Kronner Medical

K number K895172

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LXH 1989-05-15

COHN TARGETEER

Applicant Orthopedic Systems, Inc.

K number K891903

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LXH 1989-02-13

RETRACTOR, SELF-RETAINING

Applicant Dhason Brothers, Inc.

K number K890168

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LXH 1989-02-13

RONGUER-ORTHOPEDIC

Applicant Dhason Brothers, Inc.

K number K890166

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LXH 1989-02-13

HUDSON BRACE W/BURRS

Applicant Dhason Brothers, Inc.

K number K890164

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LXH 1989-02-13

AUSTIN MOORE HALLOW CHISEL

Applicant Dhason Brothers, Inc.

K number K890163

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LXH 1989-02-13

EXTRACTOR FOR AUSTIN MOORE FEMORAL HEAD

Applicant Dhason Brothers, Inc.

K number K890162

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LXH 1989-02-13

THOMPSON TYPE RASP W/TOMMY BAR

Applicant Dhason Brothers, Inc.

K number K890161

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LXH 1989-02-13

GOUGES FOR FEMORAL HEADS

Applicant Dhason Brothers, Inc.

K number K890160

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LXH 1989-02-13

RETRACTORS

Applicant Dhason Brothers, Inc.

K number K890158

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LXH 1989-02-13

FORCEPS

Applicant Dhason Brothers, Inc.

K number K890157

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LXH 1989-02-13

IMPACTOR FOR FEMORAL HEAD

Applicant Dhason Brothers, Inc.

K number K890156

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LXH 1988-11-22

TENSIOMETER

Applicant W. L. Gore & Associates, Inc.

K number K883694

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LXH 1988-06-17

MICRODISCECTOMY CURRETTES

Applicant Karlin Technology, Inc.

K number K882077

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LXH 1988-06-17

SPINAL DISTRACTORS, SPANNERS

Applicant Karlin Technology, Inc.

K number K882069

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LXH 1988-03-04

PATELLAR TENDON GRAFT GUIDE

Applicant Concept, Inc.

K number K880413

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LXH 1986-03-19

ACROMED SPINAL SURGERY INSTRUMENTS

Applicant Buckman Co., Inc.

K number K860131

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LXH 1985-08-21

ORTHOPEDIC CUSTOM SURGICAL KIT

Applicant Xanmed Corp.

K number K844595

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LXH 1985-04-15

HENNING MENISCAL SUTURE KIT

Applicant Stryker Corp.

K number K843942

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LXH 1984-06-19

CAMELBACK HANDLE-K841969-LABELING

Applicant Stainless Mfg., Inc.

K number K841970

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LXH 1984-06-19

6.5MM HEX HANDLE

Applicant Stainless Mfg., Inc.

K number K841969

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LXH 1984-03-12

NEEDLE BENDER TX8225

Applicant Today'S Machining & Design, Inc.

K number K834108

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LXH 1984-02-27

MULHOLLAN ARTHROSCOPIC NEEDLE CARRIER

Applicant Acufex Microsurgical, Inc.

K number K834370

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LXH 1984-02-27

CRANE MENISCAL SUTURE SET

Applicant Acufex Microsurgical, Inc.

K number K834369

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LXH 1984-02-27

MENISCAL SUTURING SYSTEM

Applicant Dyonics, Inc.

K number K833943

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LXH 1982-01-22

DISPOSABLE ARTHROSCOPY CANNULA SET

Applicant Clinical Technology Corp.

K number K813000

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LXH 1981-02-10

HOWMEDICA KNEE BRUSH

Applicant Howmedica Corp.

K number K803127

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LXH 1981-02-09

FEMORAL CANAL BRUSH

Applicant Richard'S Medical Equip., Inc.

K number K810267

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LXH 1980-11-12

JACOB CHUCK

Applicant Richard Wolf Medical Instruments Corp.

K number K802694

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LXH 1980-02-22

SMITH SUBTALAR PEG

Applicant Dow Corning Wright

K number K792670

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