The following data is part of a premarket notification filed by Evolution Spine, Llc with the FDA for Lumbar Interbody Fusion System (alif, Plif, Llif, Tplif).
| Device ID | K160663 |
| 510k Number | K160663 |
| Device Name: | Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF) |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | EVOLUTION SPINE, LLC 4225 OFFICE PARKWAY Dallas, TX 75204 |
| Contact | Ashton Kouzbari |
| Correspondent | John Siegel LEONINE, LLC 819 S. 5TH STREET SUITE B Temple, TX 76504 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-09 |
| Decision Date | 2016-11-16 |
| Summary: | summary |