510(k) K152566 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to Twinfix Ti Quick-T, Twinfix FT PK, Twinfix Ultra Ti, Twinfix Ultra PK, Twinfix Ultra HA Suture Anchors, FOOTPRINT Ultra OK Suture Anchors, BIORAPTOR 2.9 Suture Anchor, BIORAPTOR 2.3 PK Suture Anchor, OSTEORAPTOR
| Applicant | Smith & Nephew, Inc., Mansfield MA, US |
| Decision | Substantially Equivalent, Dec 2, 2015 |
| Received | Sep 9, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152566
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 29, 2024 | Smith & Nephew Inc. BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor. Open, Classified |
MBI | None listed |
| Dec 30, 2019 | Smith & Nephew, Inc. TwinFix Ti 2.8 mm HS Suture Anchor - Product Usage: A fixation device intended to provide secure attachment 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.