K210470 is an FDA 510(k) clearance for the C-CURVE Interbody Fusion Device. This device is classified as a Intervertebral Fusion Device With Integrated Fixation, Cervical (Class II - Special Controls, product code OVE).
Submitted by Medicrea International SA (Rillieux-La-Pape, FR). The FDA issued a Cleared decision on September 3, 2021, 198 days after receiving the submission on February 17, 2021.
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 With Or Without Supplemental Fixation..
| 510(k) Number | K210470 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 17, 2021 |
| Decision Date | September 03, 2021 |
| Days to Decision | 198 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | OVE — Intervertebral Fusion Device With Integrated Fixation, 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 With Or Without Supplemental Fixation. |