HSZ · Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment
General, Plastic Surgery · 21 CFR 878.4820 · Class 1
Overview
| Product Code | HSZ |
|---|---|
| Device Name | Instrument, Surgical, Orthopedic, Pneumatic Powered & 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 56)
Showing 20 most recent of 56 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K991588 | EMS SWISS ORTHOCLAST | (Ems Sa) Electro Medical Systems | Jul 21, 1999 | SESE |
| K972860 | CURVTEK TSR SYSTEM | Biolectron, Inc. | Oct 31, 1997 | SESE |
| K970345 | ALIGNMENT INSTRUMENT | Richard Wolf Medical Instruments Corp. | Apr 29, 1997 | SESE |
| K955084 | ASPACH 65,000 (MODIFICATION) | The Anspach Effort, Inc. | Jan 17, 1996 | SESE |
| K954080 | SODEM HIGH SPEED SYSTEM | Sodem Diffusion SA | Oct 16, 1995 | SESE |
| K944590 | ETHICON DRILL BIT AND DRILL GUIDE | ETHICON, Inc. | May 11, 1995 | SESE |
| K934336 | SPINALPLANE | Synvasive Technology, Inc. | Mar 10, 1995 | SN |
| K940276 | FILTER, DIFFUSER | Anspach Mfg., Inc. | Nov 16, 1994 | SESE |
| K942760 | PNEUMATIC WIRE TENSIONER | Smith & Nephew Richards, Inc. | Sep 6, 1994 | SESE |
| K941681 | ARTHREX CIRCULAR HARVESTING SAW | Arthrex, Inc. | Aug 25, 1994 | SESE |
| K935367 | TAVA WIRE-DRIVER | Tava Surgical Instruments | Apr 21, 1994 | SESE |
| K934431 | PNEUMATIC WIRE TENSIONER | Smith & Nephew Richards, Inc. | Jan 27, 1994 | SESE |
| K930785 | THE DE SOUTTER M182 DRILL | De Soutter Medical, Ltd. | Oct 27, 1993 | SESE |
| K930784 | THE DE SOUTTER M193 REAMER | De Soutter Medical, Ltd. | Oct 27, 1993 | SESE |
| K926547 | MEDNEXT 1000 BONE DISSECTING SYSTEM | Mednext, Inc. | Jul 22, 1993 | SESE |
| K922661 | HHI PNEUMATIC ROTARY DRILL | H&H Instruments | Sep 18, 1992 | SESE |
| K915139 | MODEL 2250-000 ZIMMER STYLE SAGITTAL SAW MODULE | Micro Surgical Instruments Corp. | Feb 5, 1992 | SESE |
| K914845 | M170 PNEUMATICALLY OPERATED OSCILLATING SAW | Desutter Medical , Ltd. | Jan 13, 1992 | SESE |
| K913629 | JOHNSON AND JOHNSON POWER SYSTEM | Johnson & Johnson Orthopaedics, Inc. | Nov 13, 1991 | SESE |
| K913559 | OSTEO COMPLETE PNEUMATIC DRILL-OSCILAIR | Osteo AG | Nov 7, 1991 | SESE |
Top Applicants
- Micro-Aire Surgical Instruments, Inc. — 8 clearances
- The Anspach Effort, Inc. — 4 clearances
- Tava Surgical Instruments — 3 clearances
- Micro Surgical Instruments Corp. — 3 clearances
- American Sterilizer Co. — 3 clearances
