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 | K153123 |
| 510k Number | K153123 |
| Device Name: | Genesys Spine Apache Interbody Fusion System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | GENESYS SPINE 1250 SOUTH CAPITOL OF TEXAS HIGHWAY BLDG 3, STE 600 Austin, TX 78746 |
| Contact | Dave Lamb |
| Correspondent | Dave Lamb GENESYS SPINE 1250 SOUTH CAPITOL OF TEXAS HIGHWAY BLDG 3, STE 600 Austin, TX 78746 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-29 |
| Decision Date | 2016-04-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M719GPH1418M0 | K153123 | 000 |
| M719GP732070 | K153123 | 000 |
| M719GP7050 | K153123 | 000 |
| M719GP631140 | K153123 | 000 |
| M719GP631120 | K153123 | 000 |
| M719GP630140 | K153123 | 000 |
| M719GP630120 | K153123 | 000 |
| M719GP53860 | K153123 | 000 |
| M719GP53840 | K153123 | 000 |
| M719GP5370 | K153123 | 000 |
| M719GP53260 | K153123 | 000 |
| M719GP5140 | K153123 | 000 |
| M719G30170 | K153123 | 000 |
| M719G30160 | K153123 | 000 |
| M719G30150 | K153123 | 000 |
| M719GP732080 | K153123 | 000 |
| M719GP732090 | K153123 | 000 |
| M719GP732100 | K153123 | 000 |
| M719GP734150 | K153123 | 000 |
| M719GP734140 | K153123 | 000 |
| M719GP734130 | K153123 | 000 |
| M719GP734120 | K153123 | 000 |
| M719GP734110 | K153123 | 000 |
| M719GP734100 | K153123 | 000 |
| M719GP734090 | K153123 | 000 |
| M719GP734080 | K153123 | 000 |
| M719GP734070 | K153123 | 000 |
| M719GP732150 | K153123 | 000 |
| M719GP732140 | K153123 | 000 |
| M719GP732130 | K153123 | 000 |
| M719GP732120 | K153123 | 000 |
| M719GP732110 | K153123 | 000 |
| M719G30140 | K153123 | 000 |