Product code HWE
- Device name
- Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.4820
- Review panel
- OR
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K143191 | IntelliSense Drill | Mcginley Innovations | 2015-02-20 |
| K102743 | ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRES | Ortho Solutions Limited | 2011-01-20 |
| K063688 | SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBE | The Anspach Effort, Inc. | 2007-01-16 |
| K050766 | EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM | Zimmer Trabecular | 2005-05-26 |
| K043310 | SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM | Synthes (Usa) | 2005-01-05 |
| K022744 | REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS | Medical Device Services | 2002-09-18 |
| K012694 | REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS | Adven Medical | 2002-02-04 |
| K012676 | REPROCESSED USED, DISPOSABLE BLADES, BURS, BITS AND TAPS | Adven Medical | 2002-02-04 |
| K990816 | AVCORE SYSTEM | Modular Cutting Systems, Inc. | 1999-09-24 |
| K973736 | AESCULAP HILAN MOTOR SYSTEM | Aesculap, Inc. | 1997-12-29 |
| K973560 | BONE GRAFT HARVESTER | Ds Mfg., Inc. | 1997-11-12 |
| K972508 | SURGICAL BURS AND SURGICAL DRILL BITS | Synvasive Technology, Inc. | 1997-08-26 |
| K971342 | DISK WHISK CUTTING DEVICE (CONICAL, ELLIPTICAL AND BALL HEAD) | Disk Whisk, Inc. | 1997-07-08 |
| K971544 | SYNTHES (USA) COMPACT AIR DRIVE II (CAD II) | Synthes (Usa) | 1997-05-28 |
| K962087 | SERVOTRONIC EC100 SYSTEM | Medicon, Inc. | 1997-04-23 |
| K970088 | RIWO DRIVE WITH FOOTSWITCH/MOTOR HANDLE, COOMPLETE,6000RPM/3000RPM/ROTARY BLADES AND ABRADERS SEE SECTION 1: | Richard Wolf Medical Instruments Corp. | 1997-04-07 |
| K970040 | SPINE-TECH BONE HARVESTER | Spine-Tech, Inc. | 1997-02-28 |
| K970023 | MEDNEXT SURGICAL BUR | Mednext, Inc. | 1997-02-28 |
| K962913 | SYNTHES STERILE DRILL BITS | Synthes (Usa) | 1996-11-14 |
| K962800 | STRYKER UNIVERSAL DRILL ATTACHMENTS & ACCESSORIES | Stryker Instruments | 1996-09-11 |
| K962215 | CONSENSUS POSTERIOR STABILIZED KNEE-INTERCONDYLAR NOTCH ROUTER | U.S. Medical Products, Inc. | 1996-08-15 |
| K962022 | POWERCUT GOLD SURGICAL SYSTEM | Baxter Healthcare Corp | 1996-08-05 |
| K961970 | COMMAND 2 MICOELECTRIC SURGICAL SYSTEM | Stryker Corp. | 1996-07-26 |
| K961759 | CEMENT AND BONE REMOVAL KIT | Maillefer Instruments S.A. | 1996-06-13 |
| K960720 | EXACTECH STERILE MODULAR DRILL BIT | Exactech, Inc. | 1996-04-23 |
| K960852 | HALL MODULAR ACETABULAR REAMER SYSTEM | Linvatec Corp. | 1996-03-20 |
| K953968 | AESCULAP POWER SYSTEMS (ELAN-E & MICROTRON) | Aesculap, Inc. | 1996-02-05 |
| K955098 | 3M MINI-DRIVER ELECTRIC SYSTEM | 3M Company | 1996-01-22 |
| K955591 | MICROAIRE SMARTDRIVE SYSTEM | Microaire Surgical Instruments, Inc. | 1996-01-18 |
| K952543 | GRAFTOLOGER PGH & ACL RECONSTRUCTION INSTRUMENT SET | Neoligaments, Ltd. | 1995-06-22 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00842078125748 | Carilaginator | EXTREMITY MEDICAL, LLC | 2026-06-09 |
| 00842078125724 | Carilaginator | EXTREMITY MEDICAL, LLC | 2026-06-09 |
| 00842078134115 | Carilaginator | EXTREMITY MEDICAL, LLC | 2026-06-09 |
| 00842078134108 | Carilaginator | EXTREMITY MEDICAL, LLC | 2026-06-09 |
| 00842078134092 | Carilaginator | EXTREMITY MEDICAL, LLC | 2026-06-09 |
| 00842078134085 | Carilaginator | EXTREMITY MEDICAL, LLC | 2026-06-09 |
| 00842078134078 | Carilaginator | EXTREMITY MEDICAL, LLC | 2026-06-09 |
| 00842078134061 | Carilaginator | EXTREMITY MEDICAL, LLC | 2026-06-09 |
| 00842078130537 | Carilaginator | EXTREMITY MEDICAL, LLC | 2026-06-09 |
| 00842078130490 | Carilaginator | EXTREMITY MEDICAL, LLC | 2026-06-09 |
| 00842078130452 | Carilaginator | EXTREMITY MEDICAL, LLC | 2026-06-09 |
| 00842078130315 | Carilaginator | EXTREMITY MEDICAL, LLC | 2026-06-09 |
| 00842078130261 | Carilaginator | EXTREMITY MEDICAL, LLC | 2026-06-09 |
| 00842078134054 | Carilaginator | EXTREMITY MEDICAL, LLC | 2026-06-09 |
| 00850078396303 | PFT Adapter, SYK, Virata, 85 in-lb (228-TXRX-006) | Eca Medical Instruments | 2026-06-05 |
| 00850078396310 | PFT Adapter, SYK, Mariner, 105 in-lb (228-TXRX-007) | Eca Medical Instruments | 2026-06-05 |
| 10705034648118 | TRIALTIS | Medos International Sàrl | 2026-06-03 |
| 10705034647838 | TRIALTIS | Medos International Sàrl | 2026-06-03 |
| 10705034647821 | TRIALTIS | Medos International Sàrl | 2026-06-03 |
| 10705034647807 | TRIALTIS | Medos International Sàrl | 2026-06-03 |
| 10705034647814 | TRIALTIS | Medos International Sàrl | 2026-06-03 |
| 00810111227292 | K-Wire | Treace Medical Concepts, Inc. | 2026-06-02 |
| 07613327648331 | PANGEA | Stryker GmbH | 2026-06-02 |
| 07613327648362 | PANGEA | Stryker GmbH | 2026-06-02 |
| 07613327652703 | N/A | STRYKER CORPORATION | 2026-04-15 |
| 07613327652710 | PROstep | STRYKER CORPORATION | 2026-04-13 |
| 07613327652734 | N/A | STRYKER CORPORATION | 2026-04-13 |
| 07613327652727 | N/A | STRYKER CORPORATION | 2026-04-13 |
| ENOU1510NOU0 | Vario-Foot control | Nouvag AG | 2017-01-13 |
| ENOU1866NOU0 | Vario-Foot control | Nouvag AG | 2017-01-13 |