K151726 is an FDA 510(k) clearance for the AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK Spacer, AVS Navigator PEEK Spacer, AVS ARIA PEEK Spacer. This device is classified as a Intervertebral Fusion Device With Bone Graft, Lumbar (Class II - Special Controls, product code MAX).
Submitted by Stryker Corporation (Allendale, US). The FDA issued a Cleared decision on January 20, 2016, 208 days after receiving the submission on June 26, 2015.
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 | K151726 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 26, 2015 |
| Decision Date | January 20, 2016 |
| Days to Decision | 208 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. |