The following data is part of a premarket notification filed by Conmed Corporation with the FDA for Crossft Knotless Suture Anchor With Disposable Driver.
| Device ID | K163258 |
| 510k Number | K163258 |
| Device Name: | CrossFT Knotless Suture Anchor With Disposable Driver |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | ConMed Corporation 525 French Road Utica, NY 13502 |
| Contact | Nyrobia Freeman |
| Correspondent | Nyrobia Freeman ConMed Corporation 525 French Road Utica, NY 13502 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-21 |
| Decision Date | 2017-01-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20845854649838 | K163258 | 000 |
| 10845854044582 | K163258 | 000 |
| 10845854044605 | K163258 | 000 |
| 10845854044612 | K163258 | 000 |
| 10845854044629 | K163258 | 000 |
| 10845854044636 | K163258 | 000 |
| 10845854044643 | K163258 | 000 |
| 10845854044650 | K163258 | 000 |
| 10845854606186 | K163258 | 000 |
| 10845854606193 | K163258 | 000 |
| 10845854606209 | K163258 | 000 |
| 10845854606216 | K163258 | 000 |
| 10845854606223 | K163258 | 000 |
| 10845854044599 | K163258 | 000 |
| 20845854649821 | K163258 | 000 |
| 10845854044568 | K163258 | 000 |