510(k) K130422 ยท NWJ Suture, Recombinant Technology
PHANTOM FIBER BIOFIBER SUTURE
| Applicant | Tornier, Inc., Bloomington MN, US |
| Decision | Substantially Equivalent, Apr 4, 2013 |
| Received | Feb 20, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K130422
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 8, 2018 | Tornier, Inc Fornier Phantom Fiber(TM) Sutures:
Item Number Description
SMB000425 4.5 MM PHANTOM FT BIOCOMPOSITE SUTURE ANCHOR WITH NEEDLES
SMB000525 5.5 MM PHANTOM FT BIOCOMPOSITE SUTURE ANCHOR WITH NEEDLES
SMP00 Terminated |
NWJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.