The following data is part of a premarket notification filed by Conmed Corporation with the FDA for Crossft Knotless Biocomposite Suture Anchor With Disposable Driver.
| Device ID | K170501 |
| 510k Number | K170501 |
| Device Name: | CrossFT Knotless Biocomposite Suture Anchor With Disposable Driver |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | ConMed Corporation 525 French Road Utica, NY 13502 |
| Contact | Diana L. Nader-martone |
| Correspondent | Diana L. Nader-martone ConMed Corporation 525 French Road Utica, NY 13502 |
| Product Code | MAI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-21 |
| Decision Date | 2017-03-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20845854045791 | K170501 | 000 |
| 10845854045787 | K170501 | 000 |
| 10845854045817 | K170501 | 000 |
| 10845854045824 | K170501 | 000 |
| 10845854045831 | K170501 | 000 |
| 10845854045848 | K170501 | 000 |
| 10845854045855 | K170501 | 000 |
| 10845854045862 | K170501 | 000 |
| 10845854045800 | K170501 | 000 |
| 30845854045798 | K170501 | 000 |