TIGER CANNULATED SCREW SYSTEM
FDA 510(k) clearance K081510 · decided 2008-08-04
Clearance details
- K-number
- K081510
- Device name
- TIGER CANNULATED SCREW SYSTEM
- Applicant
- Trilliant Surgical, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2008-05-29
- Decision date
- 2008-08-04
- Days to decision
- 67 days
- Clearance type
- Traditional
- Product code
- HWC
- Device class
- 2
- Regulation number
- 888.3040
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Round Rock, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Tiger Cannulated Tray Lid Part # 210-00-001-1 NON-STERILE; Combined Tiger/Headless Screw P recall (Z-2464-2015) | Trilliant Surgical Ltd. | 2015-08-26 |
| 3.0/4.0 Cannulated Drill Bit; a component of the Tiger Cannulated Screw System The Tiger C recall (Z-2452-2015) | Trilliant Surgical Ltd. | 2015-08-24 |
| 2.0/2.4 Cannulated Screw Countersink Part # 210-24-002 NON-STERILE and 3.0/4.0 Cannulated recall (Z-2421-2015) | Trilliant Surgical Ltd. | 2015-08-19 |
| 2.0/2.4 Cannulated Screw Driver Bit, part #210-24-003 recall (Z-1438-2010) | Trilliant Surgical LTD | 2010-04-26 |