K233223
- 510(k) number
- K233223
- Device name
- OGmend® Implant Enhancement System
- Applicant
- Woven Orthopedic Technologies CT · US
- Product code
- QVI — Screw Sleeve Bone Fixation Device, Spine
- Decision date
- 2023-10-26
- Date received
- 2023-09-28
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K233223.pdf
Official FDA record: K233223
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.