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., 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 Feb 20, 2015
IntelliSense Drill
K143191
Mcginley Innovations
Orthopedic · 106d
Cleared Jan 16, 2007
SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBE
K063688
The Anspach Effort, Inc.
Orthopedic · 35d
Cleared May 26, 2005
EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM
K050766
Zimmer Trabecular
Orthopedic · 62d
Cleared Jan 05, 2005
SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM
K043310
Synthes (Usa)
Orthopedic · 35d
Cleared Sep 24, 1999
AVCORE SYSTEM
K990816
Modular Cutting Systems, Inc.
Orthopedic · 197d
Cleared Dec 29, 1997
AESCULAP HILAN MOTOR SYSTEM
K973736
Aesculap, Inc.
Orthopedic · 89d
Cleared Nov 12, 1997
BONE GRAFT HARVESTER
K973560
Ds Mfg., Inc.
Orthopedic · 54d
Cleared Aug 26, 1997
SURGICAL BURS AND SURGICAL DRILL BITS
K972508
Synvasive Technology, Inc.
Orthopedic · 54d
Cleared Jul 08, 1997
DISK WHISK CUTTING DEVICE (CONICAL, ELLIPTICAL AND BALL HEAD)
K971342
Disk Whisk, Inc.
Orthopedic · 89d
Cleared May 28, 1997
SYNTHES (USA) COMPACT AIR DRIVE II (CAD II)
K971544
Synthes (Usa)
Orthopedic · 30d
Cleared Apr 23, 1997
SERVOTRONIC EC100 SYSTEM
K962087
Medicon, Inc.
Orthopedic · 330d
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 Feb 28, 1997
MEDNEXT SURGICAL BUR
K970023
Mednext, Inc.
Orthopedic · 56d
Cleared Feb 28, 1997
SPINE-TECH BONE HARVESTER
K970040
Spine-Tech, Inc.
Orthopedic · 53d
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 15, 1996
CONSENSUS POSTERIOR STABILIZED KNEE-INTERCONDYLAR NOTCH ROUTER
K962215
U.S. Medical Products, Inc.
Orthopedic · 66d
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 Jun 13, 1996
CEMENT AND BONE REMOVAL KIT
K961759
Maillefer Instruments S.A.
Orthopedic · 37d
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

About Product Code HWE - Regulatory Context