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 |