The following data is part of a premarket notification filed by Conmed Corporation with the FDA for Infinity Fixation System.
Device ID | K191204 |
510k Number | K191204 |
Device Name: | Infinity Fixation System |
Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
Applicant | ConMed Corporation 525 French Road Utica, NY 13502 |
Contact | Orjada Dervishleri |
Correspondent | Orjada Dervishleri ConMed Corporation 525 French Road Utica, NY 13502 |
Product Code | MBI |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-05-06 |
Decision Date | 2019-07-03 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20845854901806 | K191204 | 000 |
20845854901790 | K191204 | 000 |
10845854901786 | K191204 | 000 |
10845854901779 | K191204 | 000 |
10845854901762 | K191204 | 000 |
20845854649111 | K191204 | 000 |
20845854649104 | K191204 | 000 |
20845854649074 | K191204 | 000 |
20845854649067 | K191204 | 000 |