The following data is part of a premarket notification filed by Tornier, Inc. with the FDA for Phantom Fiber Biofiber Suture.
| Device ID | K130422 |
| 510k Number | K130422 |
| Device Name: | PHANTOM FIBER BIOFIBER SUTURE |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-20 |
| Decision Date | 2013-04-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10846832011756 | K130422 | 000 |
| 00846832011650 | K130422 | 000 |
| 10846832011664 | K130422 | 000 |
| 10846832011671 | K130422 | 000 |
| 00846832011681 | K130422 | 000 |
| 00846832011698 | K130422 | 000 |
| 10846832011701 | K130422 | 000 |
| 10846832011718 | K130422 | 000 |
| 00846832011728 | K130422 | 000 |
| 00846832011735 | K130422 | 000 |
| 10846832011749 | K130422 | 000 |
| 00846832011643 | K130422 | 000 |