K222903 is an FDA 510(k) clearance for the Tailored-H Cervical Stand Alone System. This device is classified as a Intervertebral Fusion Device With Integrated Fixation, Cervical (Class II - Special Controls, product code OVE).
Submitted by Bespoke Technologies, LLC (Winston-Salemn, US). The FDA issued a Cleared decision on November 18, 2022, 56 days after receiving the submission on September 23, 2022.
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 | K222903 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 23, 2022 |
| Decision Date | November 18, 2022 |
| Days to Decision | 56 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. |