The following data is part of a premarket notification filed by Genesys Spine with the FDA for Genesys Spine Apache® Anchored Cervical Interbody Fusion System.
| Device ID | K152099 |
| 510k Number | K152099 |
| Device Name: | Genesys Spine Apache® Anchored Cervical Interbody Fusion System |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Applicant | GENESYS SPINE 1250 CAPITAL OF TEXAS HWY BUILDING 3, SUITE 600 Austin, TX 78746 |
| Contact | Ben Keller |
| Correspondent | Benjamin V Keller GENESYS SPINE 1250 CAPITAL OF TEXAS HWY BUILDING 3, SUITE 600 Austin, TX 78746 |
| Product Code | OVE |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-28 |
| Decision Date | 2016-07-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M719GCV100XS0 | K152099 | 000 |
| M719GCV10905L0 | K152099 | 000 |
| M719GCV10811L0 | K152099 | 000 |
| M719GCV1140 | K152099 | 000 |