510(k) K093844 ยท MAI Fastener, Fixation, Biodegradable, Soft Tissue
SMITH & NEPHEW TWINFIX ULTRA HA SUTURE ANCHOR
| Applicant | Smith & Nephew, Inc., Mansfield MA, US |
| Decision | Substantially Equivalent, Apr 1, 2010 |
| Received | Dec 15, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093844
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 17, 2013 | Smith & Nephew, Inc. Endoscopy Division TWINFIX Ultra HA 4.5 mm Suture Anchor with 2 ULTRABRAID Suture, White / Blue; Part Number: 72202597
Biodegradable suture anchor Terminated |
MAI | None listed |
| Sep 17, 2013 | Smith & Nephew, Inc. Endoscopy Division TWINFIX Ultra HA 4.5 mm Suture Anchor with 2 ULTRABRAID Suture, Blue / Black; Part Number: 72202624
Biodegradable suture anchor Terminated |
MAI | None listed |
| Sep 17, 2013 | Smith & Nephew, Inc. Endoscopy Division TWINFIX Ultra HA 5.5 mm Suture Anchor with 2 ULTRABRAID Suture, Blue / Black; Part Number: 72202626
Biodegradable suture anchor Terminated |
MAI | None listed |
| Sep 17, 2013 | Smith & Nephew, Inc. Endoscopy Division TWINFIX Ultra HA 6.5 mm with 2 ULTRABRAID Suture, Blue / Black; Part Number: 72202631
Biodegradable suture anchor Terminated |
MAI | None listed |
| Sep 17, 2013 | Smith & Nephew, Inc. Endoscopy Division TWINFIX Ultra PLLA/HA 5.5 mm Suture Anchor with 2 ULTRABRAID Suture, White / Black: Part Number: 72202602
Biodegradable suture anchor Terminated |
MAI | None listed |
| Sep 17, 2013 | Smith & Nephew, Inc. Endoscopy Division TWINFIX" Ultra PLLA/HA 6.5 mm with 2 ULTRABRAID" Suture, White / Black: Part Number: 72202608
Biodegradable suture anchor Terminated |
MAI | None listed |
| Sep 17, 2013 | Smith & Nephew, Inc. Endoscopy Division TWINFIX Ultra PLLA/HA 6.5 mm with 3 ULTRABRAID Suture; Part Number: 72202610
Biodegradable suture anchor Terminated |
MAI | None listed |
| Sep 17, 2013 | Smith & Nephew, Inc. Endoscopy Division RAPTORMITE" 3.7 mm PLLA with two ULTRABRAID" Sutures Size 0 and Needles; Part Number: 72201805
Biodegradable suture anchor Terminated |
MAI | None listed |
| Sep 17, 2013 | Smith & Nephew, Inc. Endoscopy Division TWINFIX" Ultra 4.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue, blue-COBRAID") with Needles; Part Number: 72202612
Biodegradable suture anchor Terminated |
MAI | None listed |
| Sep 17, 2013 | Smith & Nephew, Inc. Endoscopy Division TWINFIX Ultra 5.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue, blue-COBRAID) with Needles; Part Number: 72202616
Biodegradable suture anchor Terminated |
MAI | None listed |
| Sep 17, 2013 | Smith & Nephew, Inc. Endoscopy Division TWINFIX Ultra 6.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue, blue-COBRAID) with Needles; Part Number: 72202620
Biodegradable suture anchor Terminated |
MAI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.