SMITH AND NEPHEW TWINFIX ULTRA TI SUTURE ANCHOR
FDA 510(k) clearance K100159 · decided 2010-04-19
Clearance details
- K-number
- K100159
- Device name
- SMITH AND NEPHEW TWINFIX ULTRA TI SUTURE ANCHOR
- Applicant
- Smith & Nephew Inc., Endoscopy Div.
- Decision
- Substantially Equivalent
- Date received
- 2010-01-20
- Decision date
- 2010-04-19
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- MBI
- Device class
- 2
- Regulation number
- 888.3040
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Andover, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Smith & Nephew 5.5 mm TWINFIX Ultra Ti Suture Anchor with two #2 ULTRABRAID sutures (blue, recall (Z-2165-2012) | Smith & Nephew, Inc. Endoscopy Division | 2012-08-09 |
| Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures(white, COBRAID-blue), st recall (Z-2166-2012) | Smith & Nephew, Inc. Endoscopy Division | 2012-08-09 |
| Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures (COBRAID-blue, COBRAIDbl recall (Z-2167-2012) | Smith & Nephew, Inc. Endoscopy Division | 2012-08-09 |
| Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with three #2 sutures (white, COBRAID- blue) recall (Z-2168-2012) | Smith & Nephew, Inc. Endoscopy Division | 2012-08-09 |