K221535 is an FDA 510(k) clearance for the Align Lumbar Interbody Fusion System. This device is classified as a Intervertebral Fusion Device With Bone Graft, Lumbar (Class II - Special Controls, product code MAX).
Submitted by Acuity Surgical Devices, LLC (Irving, US). The FDA issued a Cleared decision on July 22, 2022, 56 days after receiving the submission on May 27, 2022.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3080. Intended To Stabilize Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft..
| 510(k) Number | K221535 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 27, 2022 |
| Decision Date | July 22, 2022 |
| Days to Decision | 56 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MAX — Intervertebral Fusion Device With Bone Graft, Lumbar |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3080 |
| Definition | Intended To Stabilize Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft. |