The following data is part of a premarket notification filed by Genesys Spine with the FDA for Genesys Spine Interbody Fusion System.
| Device ID | K103034 |
| 510k Number | K103034 |
| Device Name: | GENESYS SPINE INTERBODY FUSION SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | GENESYS SPINE 1250 CAPITAL OF TEXAS HWY SO. BUILDING THREE, SUITE 600 Austin, TX 78746 |
| Contact | Josh Kaufmann |
| Correspondent | Josh Kaufmann GENESYS SPINE 1250 CAPITAL OF TEXAS HWY SO. BUILDING THREE, SUITE 600 Austin, TX 78746 |
| Product Code | MAX |
| Subsequent Product Code | MQP |
| Subsequent Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-13 |
| Decision Date | 2010-12-10 |
| Summary: | summary |