The following data is part of a premarket notification filed by Biomet Inc. with the FDA for Tunneloc Tibial Fixation Device.
| Device ID | K193092 |
| 510k Number | K193092 |
| Device Name: | TunneLoc Tibial Fixation Device |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | Biomet Inc. 56 East Bell Drive, PO Box 587 Warsaw, IN 46582 |
| Contact | Haley Pioch |
| Correspondent | Haley Pioch Biomet Inc. 56 East Bell Drive, PO Box 587 Warsaw, IN 46582 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-06 |
| Decision Date | 2020-01-02 |