LXH · Class I · 21 CFR 888.4540

FDA Product Code LXH: Orthopedic Manual Surgical Instrument

Leading manufacturers include Onyx Medical Corp., Acufex Microsurgical, Inc. and Stryker Corp..

58
Total
58
Cleared
92d
Avg days
1980
Since

FDA 510(k) Cleared Orthopedic Manual Surgical Instrument Devices (Product Code LXH)

58 devices
1–24 of 58
Cleared Dec 20, 2019
SX-One MicroKnife
K192873
Sonex Health, Inc.
Orthopedic · 73d
Cleared Jun 14, 2000
MICROPERFORATION INSTRUMENT
K001507
Smith & Nephew, Inc.
Orthopedic · 30d
Cleared Jan 22, 1996
ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEM
K952495
Orthopedic Systems, Inc.
Orthopedic · 237d
Cleared Apr 26, 1995
ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SY
K943873
Orthomet, Inc.
Orthopedic · 260d
Cleared Nov 07, 1994
STEADMAN LIGAMENT GRAFT PASSER AND PROTECTOR
K941896
Depuy, Inc.
Orthopedic · 203d
Cleared Aug 26, 1994
HYPERFLEX FLEXIBLE GUIDEWIRES
K941711
Linvatec Corp.
Orthopedic · 142d
Cleared Aug 05, 1994
STRYKER FEMORAL CANAL BRUSH, ACETABULAR BRUSH
K941605
Stryker Corp.
Orthopedic · 126d
Cleared Jan 28, 1994
SOFAMOR ORTHOPAEDIC INSTRUMENTS
K933242
Danek Medical, Inc.
Orthopedic · 210d
Cleared Feb 16, 1993
CALMPS: BONE, MASTIN, LEWIN, BRAND
K930028
Thomasville Medical Assoc.
Orthopedic · 42d
Cleared Jul 30, 1990
ADJUSTABLE ANGLE GUIDE
K903247
Onyx Medical Corp.
Orthopedic · 6d
Cleared Jul 30, 1990
DRIVER/EXTRACTOR
K903257
Onyx Medical Corp.
Orthopedic · 6d
Cleared Jul 30, 1990
T-HANDLE HEX WRENCH
K903270
Onyx Medical Corp.
Orthopedic · 6d
Cleared May 15, 1989
COHN TARGETEER
K891903
Orthopedic Systems, Inc.
Orthopedic · 49d
Cleared Nov 22, 1988
TENSIOMETER
K883694
W.L. Gore & Associates, Inc.
Orthopedic · 85d
Cleared Mar 04, 1988
PATELLAR TENDON GRAFT GUIDE
K880413
Concept, Inc.
Orthopedic · 32d
Cleared Mar 19, 1986
ACROMED SPINAL SURGERY INSTRUMENTS
K860131
Buckman Co., Inc.
Orthopedic · 64d
Cleared Apr 15, 1985
HENNING MENISCAL SUTURE KIT
K843942
Stryker Corp.
Orthopedic · 188d
Cleared Feb 27, 1984
CRANE MENISCAL SUTURE SET
K834369
Acufex Microsurgical, Inc.
Orthopedic · 76d
Cleared Feb 27, 1984
MULHOLLAN ARTHROSCOPIC NEEDLE CARRIER
K834370
Acufex Microsurgical, Inc.
Orthopedic · 76d
Cleared Feb 10, 1981
HOWMEDICA KNEE BRUSH
K803127
Howmedica Corp.
Orthopedic · 60d
Cleared Feb 09, 1981
FEMORAL CANAL BRUSH
K810267
Richard'S Medical Equip., Inc.
Orthopedic · 39d
Cleared Nov 12, 1980
JACOB CHUCK
K802694
Richard Wolf Medical Instruments Corp.
Orthopedic · 13d
Cleared Feb 22, 1980
SMITH SUBTALAR PEG
K792670
Dow Corning Wright
Orthopedic · 57d

About Product Code LXH - Regulatory Context