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 |