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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850026642094 | K211496 | 000 |
| 00850026642162 | K211496 | 000 |
| 00850026642155 | K211496 | 000 |
| 00850026642148 | K211496 | 000 |
| 00850026642131 | K211496 | 000 |
| 00850026642124 | K211496 | 000 |
| 00850026642117 | K211496 | 000 |
| 00850026642100 | K211496 | 000 |
| 00850026642018 | K211496 | 000 |
| 00850026642001 | K211496 | 000 |
| 00850026642360 | K211496 | 000 |
| 00850026642353 | K211496 | 000 |
| 00850026642346 | K211496 | 000 |
| 00850026642339 | K211496 | 000 |
| 00850026642322 | K211496 | 000 |
| 00850026642315 | K211496 | 000 |
| 00850026642179 | K211496 | 000 |
| 00850026642193 | K211496 | 000 |
| 00850026642087 | K211496 | 000 |
| 00850026642070 | K211496 | 000 |
| 00850026642063 | K211496 | 000 |
| 00850026642056 | K211496 | 000 |
| 00850026642049 | K211496 | 000 |
| 00850026642032 | K211496 | 000 |
| 00850026642025 | K211496 | 000 |
| 00850026642292 | K211496 | 000 |
| 00850026642261 | K211496 | 000 |
| 00850026642254 | K211496 | 000 |
| 00850026642247 | K211496 | 000 |
| 00850026642230 | K211496 | 000 |
| 00850026642223 | K211496 | 000 |
| 00850026642216 | K211496 | 000 |
| 00850026642209 | K211496 | 000 |
| 00850026642308 | K211496 | 000 |