Acuity Surgical Devices, LLC · Class II · Cleared Jul 22, 2022
| K-number | K221535 |
| Device name | Align Lumbar Interbody Fusion System |
| Applicant | Acuity Surgical Devices, LLC |
| Product code | MAX |
| Device class | Class II |
| Decision date | Jul 22, 2022 |
| 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