The following data is part of a premarket notification filed by Cogent Spine Llc with the FDA for Cogent Med-lif.
Device ID | K132738 |
510k Number | K132738 |
Device Name: | COGENT MED-LIF |
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 | 2013-09-03 |
Decision Date | 2014-04-15 |
Summary: | summary |