HSZ — Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment Class I
FDA Device Classification
Classification Details
- Product Code
- HSZ
- Device Class
- Class I
- Regulation Number
- 878.4820
- Submission Type
- Review Panel
- OR
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K991588 | (ems sa) electro medical systems | EMS SWISS ORTHOCLAST | July 21, 1999 |
| K972860 | biolectron | CURVTEK TSR SYSTEM | October 31, 1997 |
| K970345 | richard wolf medical instruments | ALIGNMENT INSTRUMENT | April 29, 1997 |
| K955084 | anspach effort | ASPACH 65,000 (MODIFICATION) | January 17, 1996 |
| K954080 | sodem diffusion | SODEM HIGH SPEED SYSTEM | October 16, 1995 |
| K944590 | ethicon | ETHICON DRILL BIT AND DRILL GUIDE | May 11, 1995 |
| K934336 | synvasive technology | SPINALPLANE | March 10, 1995 |
| K940276 | anspach mfg | FILTER, DIFFUSER | November 16, 1994 |
| K942760 | smith and nephew richards | PNEUMATIC WIRE TENSIONER | September 6, 1994 |
| K941681 | arthrex | ARTHREX CIRCULAR HARVESTING SAW | August 25, 1994 |
| K935367 | tava surgical instruments | TAVA WIRE-DRIVER | April 21, 1994 |
| K934431 | smith and nephew richards | PNEUMATIC WIRE TENSIONER | January 27, 1994 |
| K930785 | de soutter medical | THE DE SOUTTER M182 DRILL | October 27, 1993 |
| K930784 | de soutter medical | THE DE SOUTTER M193 REAMER | October 27, 1993 |
| K926547 | mednext | MEDNEXT 1000 BONE DISSECTING SYSTEM | July 22, 1993 |
| K922661 | h and h instruments | HHI PNEUMATIC ROTARY DRILL | September 18, 1992 |
| K915139 | micro surgical instruments | MODEL 2250-000 ZIMMER STYLE SAGITTAL SAW MODULE | February 5, 1992 |
| K914845 | desutter medical | M170 PNEUMATICALLY OPERATED OSCILLATING SAW | January 13, 1992 |
| K913629 | johnson and johnson orthopaedics | JOHNSON AND JOHNSON POWER SYSTEM | November 13, 1991 |
| K913559 | osteo | OSTEO COMPLETE PNEUMATIC DRILL-OSCILAIR | November 7, 1991 |