The following data is part of a premarket notification filed by Valeris Medical Inc. with the FDA for Bonecam Suture Anchor.
| Device ID | K193108 |
| 510k Number | K193108 |
| Device Name: | Bonecam Suture Anchor |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | Valeris Medical Inc. 200 Cobb Pkwy N, Building 200, Suite 210 Marietta, GA 30062 |
| Contact | Brendan Thies |
| Correspondent | Brendan Thies Valeris Medical Inc. 200 Cobb Pkwy N, Building 200, Suite 210 Marietta, GA 30062 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-08 |
| Decision Date | 2020-03-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10193489104523 | K193108 | 000 |