HWE · Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
General, Plastic Surgery · 21 CFR 878.4820 · Class 1
Overview
| Product Code | HWE |
|---|---|
| Device Name | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment |
| Regulation | 21 CFR 878.4820 |
| Device Class | Class 1 |
| Review Panel | General, Plastic Surgery |
Identification
Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
Recent Cleared Devices (20 of 76)
Showing 20 most recent of 76 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K143191 | IntelliSense Drill | Mcginley Innovations | Feb 20, 2015 | SESE |
| K102743 | ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRES | Ortho Solutions Limited | Jan 20, 2011 | SESE |
| K063688 | SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBE | The Anspach Effort, Inc. | Jan 16, 2007 | SESE |
| K050766 | EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM | Zimmer Trabecular | May 26, 2005 | SESE |
| K043310 | SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM | Synthes (Usa) | Jan 5, 2005 | SESE |
| K022744 | REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS | Medical Device Services | Sep 18, 2002 | SESE |
| K012694 | REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS | Adven Medical | Feb 4, 2002 | SESE |
| K012676 | REPROCESSED USED, DISPOSABLE BLADES, BURS, BITS AND TAPS | Adven Medical | Feb 4, 2002 | SESE |
| K990816 | AVCORE SYSTEM | Modular Cutting Systems, Inc. | Sep 24, 1999 | SESE |
| K973736 | AESCULAP HILAN MOTOR SYSTEM | Aesculap, Inc. | Dec 29, 1997 | SESE |
| K973560 | BONE GRAFT HARVESTER | Ds Mfg., Inc. | Nov 12, 1997 | SESE |
| K972508 | SURGICAL BURS AND SURGICAL DRILL BITS | Synvasive Technology, Inc. | Aug 26, 1997 | SESE |
| K971342 | DISK WHISK CUTTING DEVICE (CONICAL, ELLIPTICAL AND BALL HEAD) | Disk Whisk, Inc. | Jul 8, 1997 | SESE |
| K971544 | SYNTHES (USA) COMPACT AIR DRIVE II (CAD II) | Synthes (Usa) | May 28, 1997 | SESE |
| K962087 | SERVOTRONIC EC100 SYSTEM | Medicon, Inc. | Apr 23, 1997 | SESE |
| K970088 | RIWO DRIVE WITH FOOTSWITCH/MOTOR HANDLE, COOMPLETE,6000RPM/3000RPM/ROTARY BLADES AND ABRADERS SEE SECTION 1: | Richard Wolf Medical Instruments Corp. | Apr 7, 1997 | SESE |
| K970040 | SPINE-TECH BONE HARVESTER | Spine-Tech, Inc. | Feb 28, 1997 | SESE |
| K970023 | MEDNEXT SURGICAL BUR | Mednext, Inc. | Feb 28, 1997 | SESE |
| K962913 | SYNTHES STERILE DRILL BITS | Synthes (Usa) | Nov 14, 1996 | SESE |
| K962800 | STRYKER UNIVERSAL DRILL ATTACHMENTS & ACCESSORIES | Stryker Instruments | Sep 11, 1996 | SESE |
Top Applicants
- U.S. Medical Products, Inc. — 7 clearances
- United American Medical Co., Inc. — 3 clearances
- Synthes (Usa) — 3 clearances
- Stryker Corp. — 3 clearances
- Richard Wolf Medical Instruments Corp. — 3 clearances
