The following data is part of a premarket notification filed by Genesys Spine with the FDA for Genesys Spine Apache® Anterior Lumbar Interbody Fusion System.
| Device ID | K161438 |
| 510k Number | K161438 |
| Device Name: | Genesys Spine Apache® Anterior Lumbar Interbody Fusion System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | GENESYS SPINE 1250 CAPITAL OF TEXAS OF HIGHWAY SOUTH, BUILDING 3 SUITE 600 Austin, TX 78746 |
| Contact | Brian Bergeron |
| Correspondent | Brian Bergeron GENESYS SPINE 1250 CAPITAL OF TEXAS OF HIGHWAY SOUTH, BUILDING 3 SUITE 600 Austin, TX 78746 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-24 |
| Decision Date | 2016-11-08 |
| Summary: | summary |