The following data is part of a premarket notification filed by Flospine, Llc with the FDA for Largo Peek Interbody System.
| Device ID | K193255 |
| 510k Number | K193255 |
| Device Name: | Largo PEEK Interbody System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | FloSpine, LLC 3651 Fau Boulevard, Suite 400 Boca Raton, FL 33431 |
| Contact | Peter Harris |
| Correspondent | Robert A Poggie BioVera Inc. 65 Promenade Saint Louis Notre Dame De Lile Perrot, CA J7v7p2 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-26 |
| Decision Date | 2020-02-20 |