The following data is part of a premarket notification filed by Cogent Spine Llc with the FDA for Cogent Lateral Interbody System.
| Device ID | K151406 |
| 510k Number | K151406 |
| Device Name: | Cogent Lateral Interbody System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | COGENT SPINE LLC 101 N. ACACIA AVE SUITE 106 Solana Beach, CA 92075 |
| Contact | Jude Paganelli |
| Correspondent | Jude Paganelli COGENT SPINE LLC 101 N. ACACIA AVE SUITE 106 Solana Beach, CA 92075 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-26 |
| Decision Date | 2016-02-25 |
| Summary: | summary |