The following data is part of a premarket notification filed by Genesys Spine with the FDA for Genesys Spine Apache Interbody Fusion System.
| Device ID | K171656 |
| 510k Number | K171656 |
| Device Name: | Genesys Spine Apache Interbody Fusion System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Genesys Spine 1250 South Capital Of Texas Highway BLDG 3, STE 600 Austin, TX 78746 |
| Contact | Brian J. Bergeron |
| Correspondent | Brian J. Bergeron Genesys Spine 1250 South Capital Of Texas Highway BLDG 3, STE 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 | 2017-06-05 |
| Decision Date | 2017-07-13 |
| Summary: | summary |