K190291 is an FDA 510(k) clearance for the Addivation Medical Cervical Interbody System. This device is classified as a Intervertebral Fusion Device With Bone Graft, Cervical (Class II - Special Controls, product code ODP).
Submitted by Addivation Medical, LLC (Monmouth Beach, US). The FDA issued a Cleared decision on July 30, 2019, 169 days after receiving the submission on February 11, 2019.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3080. Intended To Stabilize Cervical Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft..
| 510(k) Number | K190291 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 11, 2019 |
| Decision Date | July 30, 2019 |
| Days to Decision | 169 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | ODP - Intervertebral Fusion Device With Bone Graft, Cervical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3080 |
| Definition | Intended To Stabilize Cervical Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft. |