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 |