TIGERPAW SYSTEM II
FDA 510(k) clearance K111064 · decided 2011-05-18
Clearance details
- K-number
- K111064
- Device name
- TIGERPAW SYSTEM II
- Applicant
- Laax, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-04-18
- Decision date
- 2011-05-18
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- GDW
- Device class
- 2
- Regulation number
- 878.4750
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Orinda, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| TIGERPAW System II, Part number C-TP-1507 (7 connector) The TigerPaw System II is an impla recall (Z-1461-2015) | Laax, Inc. | 2015-04-23 |
| TIGERPAW System II, Part number C-TP-1509 (9 connector) The TigerPaw System II is an impla recall (Z-1462-2015) | Laax, Inc. | 2015-04-23 |