HWE · Class I · 21 CFR 878.4820

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

Leading manufacturers include Synthes (Usa), Zimmer, Inc. and 3M Company.

76
Total
76
Cleared
110d
Avg days
1976
Since

FDA 510(k) Cleared Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment Devices (Product Code HWE)

76 devices
1–24 of 76
Cleared Jan 05, 2005
SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM
K043310
Synthes (Usa)
Orthopedic · 35d
Cleared May 28, 1997
SYNTHES (USA) COMPACT AIR DRIVE II (CAD II)
K971544
Synthes (Usa)
Orthopedic · 30d
Cleared Nov 14, 1996
SYNTHES STERILE DRILL BITS
K962913
Synthes (Usa)
Orthopedic · 111d
Cleared Aug 05, 1996
POWERCUT GOLD SURGICAL SYSTEM
K962022
Baxter Healthcare Corp
Orthopedic · 74d
Cleared Jan 22, 1996
3M MINI-DRIVER ELECTRIC SYSTEM
K955098
3M Company
Orthopedic · 76d
Cleared Jan 25, 1994
ARTHREX AR-8200 SHAVER SYSTEM
K932699
Arthrex, Inc.
Orthopedic · 236d
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 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

About Product Code HWE - Regulatory Context