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 Stryker Corp..

76
Total
76
Cleared
110d
Avg days
1976
Since
76 devices
25–48 of 76
Cleared Jan 18, 1996
MICROAIRE SMARTDRIVE SYSTEM
K955591
Microaire Surgical Instruments, Inc.
Orthopedic · 42d
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 Sep 23, 1994
SURGICAL INSTRUMENTS AND ACCESSORIES
K942956
Stryker Corp.
Orthopedic · 92d
Cleared Sep 01, 1994
TOTAL KNEE KIT
K932918
Biodynamic Technologies, Inc.
Orthopedic · 443d
Cleared Feb 22, 1994
INTERMEDICS ORTHOPEDICS DRILL BITS
K931734
Intermedics Orthopedics
Orthopedic · 321d
Cleared Jan 25, 1994
ARTHREX AR-8200 SHAVER SYSTEM
K932699
Arthrex, Inc.
Orthopedic · 236d
Cleared Jan 07, 1994
ACUFEX STERILE DRILLS
K931837
Acufex Microsurgical, Inc.
Orthopedic · 269d
Cleared Jun 08, 1992
CKS OSCILLATING SAW BLADE
K921131
Techmedica, Inc.
Orthopedic · 90d
Cleared Nov 26, 1990
ACE/WILLIAMS MICROSURGERY SAW SYSTEM
K902525
Buckman Co., Inc.
Orthopedic · 174d
Cleared Sep 14, 1990
OSCILLATING SAW BLADES # SO-305,MO-305 AND ZO-305
K903650
Micro-Aire Surgical Instruments, Inc.
Orthopedic · 32d
Cleared Jun 25, 1990
HALL MODULAR ACETABULAR REAMER SYSTEM
K902332
Zimmer, Inc.
Orthopedic · 32d
Cleared Sep 15, 1989
HALL VERSIPOWER SURGICAL INSTRUMENT SYSTEM
K895198
Zimmer, Inc.
Orthopedic · 35d
Cleared Jun 10, 1988
ACE SCREW REMOVAL TREPHINE
K882008
Buckman Co., Inc.
Orthopedic · 28d
Cleared Mar 04, 1988
PACESETTER (TM) 3500 ARTHROSCOPIC SURGICAL SYSTEM
K880150
Dyonics, Inc.
Orthopedic · 51d
Cleared Oct 15, 1987
INTRA-ARTICULAR ARTHROSCOPIC SHAVER
K874044
Medline Industries, Inc.
Orthopedic · 10d
Cleared Jun 05, 1987
MODEL 28200C MICRO-ARTHROPLASTY SYSTEM
K871717
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 32d
Cleared Mar 04, 1986
3M ARTHROSCOPIC SURGICAL SYSTEM
K855216
3M Company
Orthopedic · 64d
Cleared Feb 11, 1986
INTRA-ARTICULATED ARTHROSCOPIC POWER SYSTEM
K854987
Richard Wolf Medical Instruments Corp.
Orthopedic · 61d