The following data is part of a premarket notification filed by Conmed Corporation with the FDA for Cufflink Implant System Biocomposite.
| Device ID | K180763 |
| 510k Number | K180763 |
| Device Name: | CuffLink Implant System Biocomposite |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-23 |
| Decision Date | 2018-07-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10845854046098 | K180763 | 000 |
| 10845854046081 | K180763 | 000 |
| 10845854046074 | K180763 | 000 |
| 10845854046067 | K180763 | 000 |
| 10845854046111 | K180763 | 000 |
| 10845854046104 | K180763 | 000 |