The following data is part of a premarket notification filed by Tornier, Inc. with the FDA for Biofiber Syture.
| Device ID | K122487 |
| 510k Number | K122487 |
| Device Name: | BIOFIBER SYTURE |
| Classification | Suture, Recombinant Technology |
| Applicant | TORNIER, INC. 10801 NESBITT AVENUE Bloomington, MN 55437 |
| Contact | Lael J Pickett |
| Correspondent | Lael J Pickett TORNIER, INC. 10801 NESBITT AVENUE Bloomington, MN 55437 |
| Product Code | NWJ |
| CFR Regulation Number | 878.4494 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-15 |
| Decision Date | 2012-09-17 |
| Summary: | summary |