The following data is part of a premarket notification filed by Biomet Inc. with the FDA for Allthread Titanium Suture Anchor.
| Device ID | K192942 |
| 510k Number | K192942 |
| Device Name: | ALLthread Titanium Suture Anchor |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | Biomet Inc. 56 East Bell Drive, PO Box 587 Warsaw, IN 46581 |
| Contact | Saveetha Raghupathi |
| Correspondent | Jared Cooper Biomet Inc. 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 | 2019-10-18 |
| Decision Date | 2020-01-16 |