The following data is part of a premarket notification filed by Conmed Corporation with the FDA for 2.8 Mm/3.3 Mm Poplok Suture Anchors.
| Device ID | K181120 |
| 510k Number | K181120 |
| Device Name: | 2.8 Mm/3.3 Mm PopLok Suture Anchors |
| Classification | Fastener, Fixation, Nondegradable, 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 | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-27 |
| Decision Date | 2018-12-21 |
| Summary: | summary |