The following data is part of a premarket notification filed by Linvatec Corporation D/b/a Conmed Linvatec with the FDA for Genesys Pressft Suture Anchor.
| Device ID | K121890 |
| 510k Number | K121890 |
| Device Name: | GENESYS PRESSFT SUTURE ANCHOR |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | LINVATEC CORPORATION D/B/A CONMED LINVATEC 11311 Concept Boulevard Largo, FL 33773 |
| Contact | Lorna K Linville |
| Correspondent | Lorna K Linville LINVATEC CORPORATION D/B/A CONMED LINVATEC 11311 Concept Boulevard Largo, FL 33773 |
| Product Code | MAI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-28 |
| Decision Date | 2012-08-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20845854051167 | K121890 | 000 |
| 10845854027899 | K121890 | 000 |
| 10845854027868 | K121890 | 000 |