The following data is part of a premarket notification filed by Tornier, Inc. with the FDA for Tornier Collagen Coated Biofiber Scaffold.
| Device ID | K111337 |
| 510k Number | K111337 |
| Device Name: | TORNIER COLLAGEN COATED BIOFIBER SCAFFOLD |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | TORNIER, INC. 7701 FRANCE AVE SOUTH SUITE 600 Edina, MN 55435 |
| Contact | Howard L Schrayer |
| Correspondent | Howard L Schrayer TORNIER, INC. 7701 FRANCE AVE SOUTH SUITE 600 Edina, MN 55435 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-12 |
| Decision Date | 2012-01-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00846832010509 | K111337 | 000 |