The following data is part of a premarket notification filed by Valeris Medical with the FDA for Bonecam Suture Anchors.
| Device ID | K152255 |
| 510k Number | K152255 |
| Device Name: | BoneCam Suture Anchors |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | VALERIS MEDICAL 200 COBB PKW N, BLDG 200, STE 210 Marietta, GA 30062 |
| Contact | Daniel Lanois |
| Correspondent | Cheryl Wagoner WAGONER CONSULTING LLC PO BOX 15729 Wilmington, NC 28408 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-10 |
| Decision Date | 2015-11-16 |
| Summary: | summary |