HWE · Class I · 21 CFR 878.4820

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

Leading manufacturers include Richard Wolf Medical Instruments Corp., Synthes (Usa) and Stryker Corp..

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 16, 2007
SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBE
K063688
The Anspach Effort, Inc.
Orthopedic · 35d
Cleared Jan 05, 2005
SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM
K043310
Synthes (Usa)
Orthopedic · 35d
Cleared Dec 29, 1997
AESCULAP HILAN MOTOR SYSTEM
K973736
Aesculap, Inc.
Orthopedic · 89d
Cleared May 28, 1997
SYNTHES (USA) COMPACT AIR DRIVE II (CAD II)
K971544
Synthes (Usa)
Orthopedic · 30d
Cleared Apr 07, 1997
RIWO DRIVE WITH FOOTSWITCH/MOTOR HANDLE, COOMPLETE,6000RPM/3000RPM/ROTARY BLADES AND ABRADERS SEE SECTION 1:
K970088
Richard Wolf Medical Instruments Corp.
Orthopedic · 87d
Cleared Nov 14, 1996
SYNTHES STERILE DRILL BITS
K962913
Synthes (Usa)
Orthopedic · 111d
Cleared Sep 11, 1996
STRYKER UNIVERSAL DRILL ATTACHMENTS & ACCESSORIES
K962800
Stryker Instruments
Orthopedic · 55d
Cleared Aug 05, 1996
POWERCUT GOLD SURGICAL SYSTEM
K962022
Baxter Healthcare Corp
Orthopedic · 74d
Cleared Jul 26, 1996
COMMAND 2 MICOELECTRIC SURGICAL SYSTEM
K961970
Stryker Corp.
Orthopedic · 67d
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 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 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 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 Oct 15, 1987
INTRA-ARTICULAR ARTHROSCOPIC SHAVER
K874044
Medline Industries, Inc.
Orthopedic · 10d

About Product Code HWE - Regulatory Context