The following data is part of a premarket notification filed by Foundation Fusion Solutions, Llc (dba Cornerloc) with the FDA for Transloc 3d.
Device ID | K211496 |
510k Number | K211496 |
Device Name: | TransLoc 3D |
Classification | Sacroiliac Joint Fixation |
Applicant | Foundation Fusion Solutions, LLC (dba CornerLoc) 11916 S. Oxford Ave., Suite 206 Tulsa, OK 74137 |
Contact | Robert Compton |
Correspondent | Jeffrey Brittan Watershed Idea Foundry 1815 Aston Ave., Suite 106 Carlsbad, CA 92008 |
Product Code | OUR |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-05-13 |
Decision Date | 2022-07-27 |