HSZ — Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment Class I
FDA product code HSZ covers "Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment", a Class I medical device regulated under 21 CFR 878.4820. Submissions are reviewed by the General, Plastic Surgery panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
| K930784 | de soutter medical | THE DE SOUTTER M193 REAMER | October 27, 1993 |
| K930785 | de soutter medical | THE DE SOUTTER M182 DRILL | 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 |