The following data is part of a premarket notification filed by Conmed Corporation with the FDA for Y-knot Onestep Anchor.
| Device ID | K193606 |
| 510k Number | K193606 |
| Device Name: | Y-Knot OneStep Anchor |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | ConMed Corporation 525 French Road Utica, NY 13502 |
| Contact | Carrie Engleman |
| Correspondent | Carrie Engleman 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 | 2019-12-23 |
| Decision Date | 2020-01-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20845854902117 | K193606 | 000 |
| 20845854902100 | K193606 | 000 |
| 20845854902094 | K193606 | 000 |
| 20845854901851 | K193606 | 000 |
| 20845854901844 | K193606 | 000 |
| 20845854901837 | K193606 | 000 |
| 20845854083458 | K193606 | 000 |
| 20845854083441 | K193606 | 000 |
| 20845854083434 | K193606 | 000 |