The following data is part of a premarket notification filed by Conmed Corporation with the FDA for Paradigm All-suture Anchor 1.8mm, White/black #2.
| Device ID | K190333 |
| 510k Number | K190333 |
| Device Name: | Paradigm All-Suture Anchor 1.8mm, White/Black #2 |
| 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 | 2019-02-14 |
| Decision Date | 2019-03-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20845854901585 | K190333 | 000 |
| 20845854650292 | K190333 | 000 |