The following data is part of a premarket notification filed by Conmed Corporation with the FDA for Trushot With Y-knot Shallow All-suture Anchor.
| Device ID | K182439 |
| 510k Number | K182439 |
| Device Name: | TruShot With Y-Knot Shallow All-Suture Anchor |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-07 |
| Decision Date | 2019-01-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30845854850095 | K182439 | 000 |
| 30845854850088 | K182439 | 000 |
| 20653405988417 | K182439 | 000 |
| 20653405988400 | K182439 | 000 |