The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Ventix Suture Anchor.
| Device ID | K153558 |
| 510k Number | K153558 |
| Device Name: | Ventix Suture Anchor |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE PO BOX 587 Warsaw, IN 46581 |
| Contact | Adam Cargill |
| Correspondent | Adam Cargill BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE PO BOX 587 Warsaw, IN 46581 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-14 |
| Decision Date | 2016-04-21 |
| Summary: | summary |