The following data is part of a premarket notification filed by Conmed Linvatec with the FDA for Crossft Oc Suture Anchor Mode Cfc-4502, Cfc-5502, Cfc-6502, Cfc-4503, Cfc-5503, Cfc-6503.
| Device ID | K101100 |
| 510k Number | K101100 |
| Device Name: | CROSSFT OC SUTURE ANCHOR MODE CFC-4502, CFC-5502, CFC-6502, CFC-4503, CFC-5503, CFC-6503 |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | CONMED LINVATEC 11311 CONCEPT BOULEVARD Largo, FL 33773 -4908 |
| Contact | John Cusack |
| Correspondent | John Cusack CONMED LINVATEC 11311 CONCEPT BOULEVARD Largo, FL 33773 -4908 |
| Product Code | MAI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-20 |
| Decision Date | 2010-08-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30845854042483 | K101100 | 000 |
| 20845854034580 | K101100 | 000 |
| 20845854034573 | K101100 | 000 |
| 20845854034566 | K101100 | 000 |
| 20845854026783 | K101100 | 000 |
| 20845854026776 | K101100 | 000 |
| 10845854034620 | K101100 | 000 |
| 10845854034613 | K101100 | 000 |
| 10845854034606 | K101100 | 000 |
| 10845854026816 | K101100 | 000 |
| 10845854026809 | K101100 | 000 |
| 20845854034597 | K101100 | 000 |
| 20845854042455 | K101100 | 000 |
| 20845854042721 | K101100 | 000 |
| 20845854042714 | K101100 | 000 |
| 20845854042707 | K101100 | 000 |
| 20845854042691 | K101100 | 000 |
| 20845854042684 | K101100 | 000 |
| 20845854042677 | K101100 | 000 |
| 20845854042509 | K101100 | 000 |
| 20845854042493 | K101100 | 000 |
| 20845854042479 | K101100 | 000 |
| 20845854042462 | K101100 | 000 |
| 10845854026793 | K101100 | 000 |