The following data is part of a premarket notification filed by Tornier, Inc. with the FDA for Tornier Biofiber Scaffold.
| Device ID | K102788 |
| 510k Number | K102788 |
| Device Name: | TORNIER BIOFIBER SCAFFOLD |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | TORNIER, INC. 100 CUMMINGS CENTER SUITE 444C Beverly, MA 01915 |
| Contact | Lael J Pickett |
| Correspondent | Lael J Pickett TORNIER, INC. 100 CUMMINGS CENTER SUITE 444C Beverly, MA 01915 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-24 |
| Decision Date | 2011-05-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00846832010530 | K102788 | 000 |
| 00846832010523 | K102788 | 000 |
| 00846832010493 | K102788 | 000 |
| 00846832010486 | K102788 | 000 |
| 10846832006080 | K102788 | 000 |
| 10846832006059 | K102788 | 000 |