The following data is part of a premarket notification filed by Conmed Corporation with the FDA for Microlink All-suture Button Fixation System (radiopaque).
| Device ID | K190582 |
| 510k Number | K190582 |
| Device Name: | MicroLink All-Suture Button Fixation System (Radiopaque) |
| Classification | Washer, Bolt Nut |
| 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 | HTN |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-06 |
| Decision Date | 2019-06-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30845854648906 | K190582 | 000 |
| 30845854648890 | K190582 | 000 |
| 40845854648903 | K190582 | 000 |
| 40845854648897 | K190582 | 000 |