HWE · Class I · 21 CFR 878.4820

FDA Product Code HWE: Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment

Leading manufacturers include U.S. Medical Products, Inc., Richard Wolf Medical Instruments Corp. and Synthes (Usa).

76
Total
76
Cleared
110d
Avg days
1976
Since
76 devices
25–48 of 76
Cleared Apr 23, 1996
EXACTECH STERILE MODULAR DRILL BIT
K960720
Exactech, Inc.
Orthopedic · 61d
Cleared Mar 20, 1996
HALL MODULAR ACETABULAR REAMER SYSTEM
K960852
Linvatec Corp.
Orthopedic · 19d
Cleared Feb 05, 1996
AESCULAP POWER SYSTEMS (ELAN-E & MICROTRON)
K953968
Aesculap, Inc.
Orthopedic · 167d
Cleared Jan 22, 1996
3M MINI-DRIVER ELECTRIC SYSTEM
K955098
3M Company
Orthopedic · 76d
Cleared Jan 18, 1996
MICROAIRE SMARTDRIVE SYSTEM
K955591
Microaire Surgical Instruments, Inc.
Orthopedic · 42d
Cleared Jun 22, 1995
GRAFTOLOGER PGH & ACL RECONSTRUCTION INSTRUMENT SET
K952543
Neoligaments, Ltd.
Orthopedic · 35d
Cleared May 05, 1995
CONSENSUS(TM) ORTHOPEDIC DRILL BIT
K950013
U.S. Medical Products, Inc.
Orthopedic · 122d
Cleared Apr 05, 1995
CONSENSUS(TM) PATELLA REAMER
K946197
U.S. Medical Products, Inc.
Orthopedic · 106d
Cleared Feb 01, 1995
CONSENUS HIP SYSTEM FEMORAL CANAL STARTER REAMER
K944946
U.S. Medical Products, Inc.
Orthopedic · 117d
Cleared Jan 27, 1995
CONSENUS HIP SYSTEM -- ACETABULAR REAMER
K945186
U.S. Medical Products, Inc.
Orthopedic · 95d
Cleared Jan 27, 1995
CONSENSUS HIP SYSTEM -- CALCAR PLANER
K945189
U.S. Medical Products, Inc.
Orthopedic · 95d
Cleared Jan 27, 1995
CONSENSUS HIP SYSTEM -- TROCHANTERIC CUTTER
K945208
U.S. Medical Products, Inc.
Orthopedic · 94d
Cleared Dec 15, 1994
STRYKER TOTAL PERFORMANCE SYSTEM
K943589
Stryker Corp.
Orthopedic · 146d
Cleared Oct 11, 1994
COHORT BONE BRUSH
K942108
Advanced Med/Surg, Inc.
Orthopedic · 162d
Cleared Sep 23, 1994
SURGICAL INSTRUMENTS AND ACCESSORIES
K942956
Stryker Corp.
Orthopedic · 92d
Cleared Sep 07, 1994
HALL MICROCHOICE ELECTRIC POWERED SYSTEM
K942660
Hall Surgical, Division of Zimmer, Inc.
Orthopedic · 93d
Cleared Sep 01, 1994
TOTAL KNEE KIT
K932918
Biodynamic Technologies, Inc.
Orthopedic · 443d
Cleared Apr 29, 1994
COOL CUT
K931429
Mitab
Orthopedic · 403d
Cleared Apr 25, 1994
THE GRAFTOLOGER
K935753
Neoligaments, Ltd.
Orthopedic · 150d
Cleared Feb 22, 1994
INTERMEDICS ORTHOPEDICS DRILL BITS
K931734
Intermedics Orthopedics
Orthopedic · 321d
Cleared Jan 28, 1994
SNAP BONE REAMER
K935322
Surgiquip, Inc.
Orthopedic · 85d
Cleared Jan 27, 1994
SNAP DRILL
K935516
Surgiquip, Inc.
Orthopedic · 70d
Cleared Jan 26, 1994
BONE SAW BLADES
K931176
Betzler Mfg., Inc.
Orthopedic · 323d
Cleared Jan 25, 1994
ARTHREX AR-8200 SHAVER SYSTEM
K932699
Arthrex, Inc.
Orthopedic · 236d