LXH · Class I · 21 CFR 888.4540

FDA Product Code LXH: Orthopedic Manual Surgical Instrument

Leading manufacturers include Dhason Brothers, Inc., Advanced Med/Surg, Inc. and Mumtaz I. Malik.

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 Apr 01, 2014
IMBIBE NEEDLE
K140414
Orthovita, Inc.
Orthopedic · 42d
Cleared Dec 09, 2010
SELF RETAINING SOFT TISSUE RETRACTOR
K101609
Koros USA, Inc.
Orthopedic · 184d
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 Apr 13, 1995
SPINAL MARKER
K944188
Leibinger L.P.
Orthopedic · 230d
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 Feb 01, 1994
PUNCH SURGICAL
K933772
Mahe-Medizintechnik
Orthopedic · 187d
Cleared Jan 28, 1994
SOFAMOR ORTHOPAEDIC INSTRUMENTS
K933242
Danek Medical, Inc.
Orthopedic · 210d
Cleared Jan 26, 1994
BARRIER BONE WAX APPLICATOR
K934260
Phillips Pharmaceuticals, Inc.
Orthopedic · 148d
Cleared Jan 21, 1994
BIO-PREP
K931846
Biomedical Devices, Inc.
Orthopedic · 283d
Cleared Feb 16, 1993
CALMPS: BONE, MASTIN, LEWIN, BRAND
K930028
Thomasville Medical Assoc.
Orthopedic · 42d
Cleared Jun 04, 1992
SURGICAL INSTRUMENT, DISPOSABLE
K921402
Macro Medical, Inc.
Orthopedic · 72d
Cleared Jun 03, 1992
AMSEN DOUBLE-ENDED FORAMINAL PROBE
K921642
Advanced Med/Surg, Inc.
Orthopedic · 58d
Cleared Jun 03, 1992
AMSEN POSTERIOR DISC EVACUATOR
K921643
Advanced Med/Surg, Inc.
Orthopedic · 58d
Cleared Jun 03, 1992
AMSEN HOCKEY STICK CHISEL
K921644
Advanced Med/Surg, Inc.
Orthopedic · 58d
Cleared Jun 03, 1992
AMSEN SPINE IMPACTOR INSTRUMENTS
K921645
Advanced Med/Surg, Inc.
Orthopedic · 58d
Cleared Sep 28, 1990
RONGEUR, ORTHOPEDIC SURGICAL INSTRUMENTS
K901289
Mumtaz I. Malik
Physical Medicine · 192d
Cleared Sep 28, 1990
VOLKMAN BONE CURRETTE 5, 5-3/4, 6-3/4, 8
K901420
Mumtaz I. Malik
Orthopedic · 186d
Cleared Sep 28, 1990
CHISEL, BONE, SURGICAL
K901511
Mumtaz I. Malik
Physical Medicine · 183d
Cleared Sep 28, 1990
OSTEOTOMES OF VARIOUS TYPES
K901521
Mumtaz I. Malik
Physical Medicine · 179d

About Product Code LXH - Regulatory Context