The following data is part of a premarket notification filed by Conmed Corporation with the FDA for Microlink All-suture Button Fixation System (radiolucent).
Device ID | K190516 |
510k Number | K190516 |
Device Name: | MicroLink All-Suture Button Fixation System (Radiolucent) |
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 | 2019-03-04 |
Decision Date | 2019-06-28 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
30845854648876 | K190516 | 000 |
30845854648869 | K190516 | 000 |
40845854648873 | K190516 | 000 |
40845854648866 | K190516 | 000 |