ALIGNMENT INSTRUMENT
FDA 510(k) clearance K970345 · decided 1997-04-29
Clearance details
- K-number
- K970345
- Device name
- ALIGNMENT INSTRUMENT
- Applicant
- Richard Wolf Medical Instruments Corp.
- Decision
- Substantially Equivalent
- Date received
- 1997-01-29
- Decision date
- 1997-04-29
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- HSZ
- Device class
- 1
- Regulation number
- 878.4820
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Vernon Hills, IL, US
- Third-party review
- No
- Expedited review
- No
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| ETHICON DRILL BIT AND DRILL GUIDE (K944590) | ETHICON, Inc. | 1995-05-11 |
| SPINALPLANE (K934336) | Synvasive Technology, Inc. | 1995-03-10 |
| FILTER, DIFFUSER (K940276) | Anspach Mfg., Inc. | 1994-11-16 |
| PNEUMATIC WIRE TENSIONER (K942760) | Smith & Nephew Richards, Inc. | 1994-09-06 |
| ARTHREX CIRCULAR HARVESTING SAW (K941681) | Arthrex, Inc. | 1994-08-25 |
| TAVA WIRE-DRIVER (K935367) | Tava Surgical Instruments | 1994-04-21 |
| PNEUMATIC WIRE TENSIONER (K934431) | Smith & Nephew Richards, Inc. | 1994-01-27 |
| THE DE SOUTTER M182 DRILL (K930785) | De Soutter Medical, Ltd. | 1993-10-27 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| HULKA CLIP FOR TUBAL OCCLUSION (P870080/S002) | Richard Wolf Medical Instruments Corp. | 2016-10-14 |
| HULKA CLIP FOR TUBAL OCCLUSION (P870080/S001) | Richard Wolf Medical Instruments Corp. | 1998-03-12 |
| HULKA CLIP FOR TUBAL OCCLUSION (P870080) | Richard Wolf Medical Instruments Corp. | 1996-09-05 |
| RICHARD WOLF PIEZOLITH E.L.P. LITHOTRIPT MODEL2300 (P890013) | Richard Wolf Medical Instruments Corp. | 1991-09-09 |