The following data is part of a premarket notification filed by Tornier, Inc. with the FDA for Tornier Insite Ft Biocomposite Suture Anchor.
| Device ID | K122635 |
| 510k Number | K122635 |
| Device Name: | TORNIER INSITE FT BIOCOMPOSITE SUTURE ANCHOR |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| 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 | MAI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-29 |
| Decision Date | 2013-05-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00846832060726 | K122635 | 000 |
| 00846832060719 | K122635 | 000 |
| 00846832011506 | K122635 | 000 |
| 00846832011490 | K122635 | 000 |
| 00846832011483 | K122635 | 000 |
| 00846832011476 | K122635 | 000 |
| 00846832011469 | K122635 | 000 |