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 |
| K012676 | REPROCESSED USED, DISPOSABLE BLADES, BURS, BITS AND TAPS | Adven Medical | 2002-02-04 |
| K012694 | REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS | 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 |
| K970023 | MEDNEXT SURGICAL BUR | Mednext, Inc. | 1997-02-28 |
| K970040 | SPINE-TECH BONE HARVESTER | Spine-Tech, 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 |
|---|---|---|---|
| 03700879515540 | airlock® | NOVASTEP | 2026-07-10 |
| 00643169465879 | MSB CD HORIZON Spinal System | MEDTRONIC SOFAMOR DANEK, INC. | 2026-06-28 |
| 04589551366217 | P300-2A100 | NAKANISHI INC. | 2026-06-26 |
| 04589551366262 | P300-2A120 | NAKANISHI INC. | 2026-06-26 |
| 04589551366316 | P300-2S100 | NAKANISHI INC. | 2026-06-26 |
| 04589551366361 | P300-2S120 | NAKANISHI INC. | 2026-06-26 |
| 04589551366422 | PD-IN-2-120 | NAKANISHI INC. | 2026-06-26 |
| 10886982237217 | NA | SYNTHES (U.S.A.) LP | 2019-02-21 |
| 10886982237613 | NA | Synthes GmbH | 2017-02-20 |
| 10886982240347 | NA | Synthes GmbH | 2016-12-31 |
| 10886982240385 | NA | Synthes GmbH | 2016-12-31 |
| 10886982240361 | NA | Synthes GmbH | 2016-12-31 |
| 10886982240323 | NA | Synthes GmbH | 2016-12-31 |
| 10886982237989 | NA | Synthes GmbH | 2016-12-31 |
| 10886982237729 | NA | Synthes GmbH | 2016-12-31 |
| 10886982129598 | NA | Synthes GmbH | 2016-12-31 |
| 10886982129512 | NA | Synthes GmbH | 2016-12-31 |
| 10886982238795 | NA | Synthes GmbH | 2016-12-31 |
| 10886982065001 | NA | SYNTHES (U.S.A.) LP | 2016-06-30 |
| 10886982064943 | NA | SYNTHES (U.S.A.) LP | 2016-06-30 |
| 10886982064936 | NA | SYNTHES (U.S.A.) LP | 2016-06-30 |
| 10886982064929 | NA | SYNTHES (U.S.A.) LP | 2016-06-30 |
| 10886982064912 | NA | Synthes GmbH | 2016-06-30 |
| 10886982064905 | NA | SYNTHES (U.S.A.) LP | 2016-06-30 |
| 10886982064882 | NA | SYNTHES (U.S.A.) LP | 2016-06-30 |
| 10886982064844 | NA | SYNTHES (U.S.A.) LP | 2016-06-30 |
| 10886982064820 | NA | SYNTHES (U.S.A.) LP | 2016-06-30 |
| 10886982064745 | NA | SYNTHES (U.S.A.) LP | 2016-06-30 |
| 10886982064738 | NA | Synthes GmbH | 2016-06-30 |
| 10886982064721 | NA | Synthes GmbH | 2016-06-30 |