510(k) K100159 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
SMITH AND NEPHEW TWINFIX ULTRA TI SUTURE ANCHOR
| Applicant | Smith & Nephew Inc., Endoscopy Div., Andover MA, US |
| Decision | Substantially Equivalent, Apr 19, 2010 |
| Received | Jan 20, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100159
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 9, 2012 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew 5.5 mm TWINFIX Ultra Ti Suture Anchor with two #2 ULTRABRAID sutures (blue, blue-COBRAID) with Needles
Product Usage: intended for use for the
reattachment of soft tissue to bone
Part Terminated |
MBI | None listed |
| Aug 9, 2012 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures(white, COBRAID-blue), sterile
Part Number: 72202895
Product Usage: intended for use for the
reattachment of soft tissue to bone Terminated |
MBI | None listed |
| Aug 9, 2012 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures (COBRAID-blue, COBRAIDblack), sterile
Part Number: 72202896
Product Usage: intended for use for the
reattachment of soft tissue to b Terminated |
MBI | None listed |
| Aug 9, 2012 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with three #2 sutures (white, COBRAID- blue), sterile
Part Number: 72202897
Product Usage: intended for use for the
reattachment of soft tissue to bone Terminated |
MBI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.