510(k) K122059 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
ALL-SUTURE ANCHOR TWIST DRILL FOR ALL-SUTURE ANCHORS INLINE DRILL GUIDE FOR ALL-SUTURE ANCHORS
| Applicant | Smith & Nephew, Inc., Andover MA, US |
| Decision | Substantially Equivalent, Mar 18, 2013 |
| Received | Jul 13, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122059
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 24, 2020 | Smith & Nephew, Inc. SUTUREFIX ULTRA Suture, Product number 72203855 Open, Classified |
MBI | None listed |
| Jul 14, 2014 | Smith & Nephew, Inc. Endoscopy Division SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Blue
Product Code: 72203841
Fastener, fixation, nondegradable, soft tissue Terminated |
MBI | None listed |
| Jul 14, 2014 | Smith & Nephew, Inc. Endoscopy Division SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Cobraid Suture
Product Code: 72203842
Fastener, fixation, nondegradable, soft tissue Terminated |
MBI | None listed |
| Jul 14, 2014 | Smith & Nephew, Inc. Endoscopy Division SUTUREFIX Ultra S with 1 #2 Ultrabraid (blue)
Product Code: 72203852
Fastener, fixation, nondegradable, soft tissue Terminated |
MBI | None listed |
| Jul 14, 2014 | Smith & Nephew, Inc. Endoscopy Division SUTUREFIX Ultra S with 1 #2 Ultrabraid Suture (blue/white)
Product Code: 72203853
Fastener, fixation, nondegradable, soft tissue Terminated |
MBI | None listed |
| Jul 14, 2014 | Smith & Nephew, Inc. Endoscopy Division SUTUREFIX Ultra S Double Loaded Suture
Product Code: 72203854
Fastener, fixation, nondegradable, soft tissue Terminated |
MBI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.