Panels › General, Plastic Surgery › Product code NWJ · Class 2
Suture, Recombinant Technology
Regulation 878.4494
0510(k)s in 12 months (9 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in NWJ
| Company | 510(k)s | Recalls |
|---|---|---|
| Tepha, Inc. | 5 | 0 |
| Tornier, Inc. | 2 | 1 |
| Aesculap, Inc. | 1 | 0 |
| Entrigue Surgical, Inc. | 1 | 0 |
| 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 | K130422 |
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