The following data is part of a premarket notification filed by Evolution Spine, Llc with the FDA for Cervical Interbody Fusion System.
| Device ID | K160324 |
| 510k Number | K160324 |
| Device Name: | Cervical Interbody Fusion System |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| 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 | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-05 |
| Decision Date | 2016-05-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00195860005835 | K160324 | 000 |
| 00195860005637 | K160324 | 000 |
| 00195860005620 | K160324 | 000 |
| 00195860005613 | K160324 | 000 |
| 00195860005606 | K160324 | 000 |
| 00195860005590 | K160324 | 000 |
| 00195860005583 | K160324 | 000 |
| 00195860005576 | K160324 | 000 |
| 00195860005569 | K160324 | 000 |
| 00195860005552 | K160324 | 000 |
| 00195860005545 | K160324 | 000 |
| 00195860005538 | K160324 | 000 |
| 00195860005521 | K160324 | 000 |
| 00195860005514 | K160324 | 000 |
| 00195860005507 | K160324 | 000 |
| 00195860005491 | K160324 | 000 |
| 00195860005484 | K160324 | 000 |
| 00195860005477 | K160324 | 000 |
| 00195860005644 | K160324 | 000 |
| 00195860005651 | K160324 | 000 |
| 00195860005828 | K160324 | 000 |
| 00195860005811 | K160324 | 000 |
| 00195860005804 | K160324 | 000 |
| 00195860005798 | K160324 | 000 |
| 00195860005781 | K160324 | 000 |
| 00195860005774 | K160324 | 000 |
| 00195860005767 | K160324 | 000 |
| 00195860005750 | K160324 | 000 |
| 00195860005743 | K160324 | 000 |
| 00195860005736 | K160324 | 000 |
| 00195860005729 | K160324 | 000 |
| 00195860005712 | K160324 | 000 |
| 00195860005705 | K160324 | 000 |
| 00195860005699 | K160324 | 000 |
| 00195860005682 | K160324 | 000 |
| 00195860005675 | K160324 | 000 |
| 00195860005668 | K160324 | 000 |
| 00195860005460 | K160324 | 000 |