K222554 is an FDA 510(k) clearance for the EL CAPITAN Anterior Lumbar Interbody Fusion. This device is classified as a Intervertebral Fusion Device With Integrated Fixation, Lumbar (Class II — Special Controls, product code OVD).
Submitted by Astura Medical (Irving, US). The FDA issued a Cleared decision on January 19, 2023, 149 days after receiving the submission on August 23, 2022.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3080. Intended To Stabilize Lumbar Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft With Or Without Supplemental Fixation..
| 510(k) Number | K222554 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 23, 2022 |
| Decision Date | January 19, 2023 |
| Days to Decision | 149 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | OVD — Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 888.3080 |
| Definition | Intended To Stabilize Lumbar Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft With Or Without Supplemental Fixation. |