The following data is part of a premarket notification filed by Conmed Corporation with the FDA for Cufflink Implant System.
| Device ID | K171725 |
| 510k Number | K171725 |
| Device Name: | CuffLink Implant System |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | CONMED Corporation 525 French Road Utica, NY 13502 |
| Contact | Dionne Sanders |
| Correspondent | Dionne Sanders CONMED Corporation 525 French Road Utica, NY 13502 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-12 |
| Decision Date | 2017-09-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10845854045213 | K171725 | 000 |
| 10845854045206 | K171725 | 000 |
| 10845854045190 | K171725 | 000 |
| 10845854045183 | K171725 | 000 |
| 10845854045176 | K171725 | 000 |
| 10845854045169 | K171725 | 000 |