The following data is part of a premarket notification filed by Linvatec Corporation D/b/a Conmed Linvatec with the FDA for Nano Suture Anchor.
| Device ID | K112965 |
| 510k Number | K112965 |
| Device Name: | NANO SUTURE ANCHOR |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | LINVATEC CORPORATION D/B/A CONMED LINVATEC 11311 Concept Boulevard Largo, FL 33773 |
| Contact | Ashlea Ricci |
| Correspondent | Ashlea Ricci LINVATEC CORPORATION D/B/A CONMED LINVATEC 11311 Concept Boulevard Largo, FL 33773 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-05 |
| Decision Date | 2011-11-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20845854036652 | K112965 | 000 |
| 20845854036645 | K112965 | 000 |
| 20845854036638 | K112965 | 000 |
| 20845854036621 | K112965 | 000 |
| 20845854036614 | K112965 | 000 |
| 20845854036607 | K112965 | 000 |
| 20845854051150 | K112965 | 000 |
| 20845854051136 | K112965 | 000 |