The following data is part of a premarket notification filed by Genesys Spine with the FDA for Genesys Spine Apache Ibfd Star Cervical System.
| Device ID | K130317 |
| 510k Number | K130317 |
| Device Name: | GENESYS SPINE APACHE IBFD STAR CERVICAL SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | GENESYS SPINE 1250 CAPITAL OF TEXAS HWY SO. BUILDING THREE, SUITE 600 Austin, TX 78746 |
| Contact | William W Sowers |
| Correspondent | William W Sowers GENESYS SPINE 1250 CAPITAL OF TEXAS HWY SO. BUILDING THREE, SUITE 600 Austin, TX 78746 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-08 |
| Decision Date | 2013-12-11 |
| Summary: | summary |