FDA 510(k) Applications for Medical Device Product Code "HWE"
(Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K955098 | 3M COMPANY | 3M MINI-DRIVER ELECTRIC SYSTEM | 01/22/1996 |
| K012694 | ADVEN MEDICAL | REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS | 02/04/2002 |
| K012676 | ADVEN MEDICAL | REPROCESSED USED, DISPOSABLE BLADES, BURS, BITS AND TAPS | 02/04/2002 |
| K973736 | AESCULAP, INC. | AESCULAP HILAN MOTOR SYSTEM | 12/29/1997 |
| K953968 | AESCULAP, INC. | AESCULAP POWER SYSTEMS (ELAN-E & MICROTRON) | 02/05/1996 |
| K962022 | BAXTER HEALTHCARE CORP. | POWERCUT GOLD SURGICAL SYSTEM | 08/05/1996 |
| K971342 | DISK WHISK, INC. | DISK WHISK CUTTING DEVICE (CONICAL, ELLIPTICAL AND BALL HEAD) | 07/08/1997 |
| K973560 | DS MFG., INC. | BONE GRAFT HARVESTER | 11/12/1997 |
| K960720 | EXACTECH, INC. | EXACTECH STERILE MODULAR DRILL BIT | 04/23/1996 |
| K960852 | LINVATEC CORP. | HALL MODULAR ACETABULAR REAMER SYSTEM | 03/20/1996 |
| K961759 | MAILLEFER INSTRUMENTS S.A. | CEMENT AND BONE REMOVAL KIT | 06/13/1996 |
| K143191 | McGinley Innovations | IntelliSense Drill | 02/20/2015 |
| K022744 | MEDICAL DEVICE SERVICES | REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS | 09/18/2002 |
| K962087 | MEDICON, INC. | SERVOTRONIC EC100 SYSTEM | 04/23/1997 |
| K970023 | MEDNEXT, INC. | MEDNEXT SURGICAL BUR | 02/28/1997 |
| K955591 | MICROAIRE SURGICAL INSTRUMENTS, INC. | MICROAIRE SMARTDRIVE SYSTEM | 01/18/1996 |
| K990816 | MODULAR CUTTING SYSTEMS, INC. | AVCORE SYSTEM | 09/24/1999 |
| K102743 | ORTHO SOLUTIONS LIMITED | ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRES | 01/20/2011 |
| K970088 | RICHARD WOLF MEDICAL INSTRUMENTS CORP. | RIWO DRIVE WITH FOOTSWITCH/MOTOR HANDLE, COOMPLETE,6000RPM/3000RPM/ROTARY BLADES AND ABRADERS SEE SECTION 1: | 04/07/1997 |
| K970040 | SPINE-TECH, INC. | SPINE-TECH BONE HARVESTER | 02/28/1997 |
| K961970 | STRYKER CORP. | COMMAND 2 MICOELECTRIC SURGICAL SYSTEM | 07/26/1996 |
| K962800 | STRYKER INSTRUMENTS | STRYKER UNIVERSAL DRILL ATTACHMENTS & ACCESSORIES | 09/11/1996 |
| K971544 | SYNTHES (USA) | SYNTHES (USA) COMPACT AIR DRIVE II (CAD II) | 05/28/1997 |
| K043310 | SYNTHES (USA) | SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM | 01/05/2005 |
| K962913 | SYNTHES (USA) | SYNTHES STERILE DRILL BITS | 11/14/1996 |
| K972508 | SYNVASIVE TECHNOLOGY, INC. | SURGICAL BURS AND SURGICAL DRILL BITS | 08/26/1997 |
| K063688 | THE ANSPACH EFFORT, INC. | SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBE | 01/16/2007 |
| K962215 | U.S. MEDICAL PRODUCTS, INC. | CONSENSUS POSTERIOR STABILIZED KNEE-INTERCONDYLAR NOTCH ROUTER | 08/15/1996 |
| K050766 | ZIMMER TRABECULAR | EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM | 05/26/2005 |
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