The following data is part of a premarket notification filed by Genesys Spine with the FDA for Genesys Spine Apache® Lateral Lumbar Interbody Fusion System.
| Device ID | K161404 |
| 510k Number | K161404 |
| Device Name: | Genesys Spine Apache® Lateral 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 | Dave Lamb |
| Correspondent | Dave Lamb 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-20 |
| Decision Date | 2016-07-21 |
| Summary: | summary |