510(k) K223075
- Device
- Ogmend® Implant Enhancement System
- Applicant
- Woven Orthopedic Technologies
- 510(k) number
- K223075
- Product code
- QVI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-02-27
- Date received
- 2022-09-30
- Regulation
- 888.3043
- Classification name
- Screw Sleeve Bone Fixation Device, Spine
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Brandon Bendes
- Address
- 63 Center St. #3a Manchester CT US 06040 06040
FDA Registration Numbers#
- 1220477
- 3013378907
- 3017505709
Source Documents#
Other 510(k) Records For Product Code QVI#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K233223 | OGmend® Implant Enhancement System | Woven Orthopedic Technologies | 2023-10-26 |