Genesys Spine · Class II · Cleared Jul 21, 2016
| K-number | K161404 |
| Device name | Genesys Spine Apache® Lateral Lumbar Interbody Fusion System |
| Applicant | Genesys Spine |
| Product code | MAX |
| Device class | Class II |
| Decision date | Jul 21, 2016 |
| Decision | Substantially Equivalent |
| Regulation | 888.3080 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov