510(k) K223075
K223075 is an FDA 510(k) premarket notification submitted by Woven Orthopedic Technologies for the device "Ogmend® Implant Enhancement System". The FDA issued a decision of Substantially Equivalent on February 27, 2023. The device falls under product code QVI (Screw Sleeve Bone Fixation Device, Spine), a Class II device regulated under 21 CFR 888.3043. Woven Orthopedic Technologies has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 27, 2023
- Date Received
- September 30, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Screw Sleeve Bone Fixation Device, Spine
- Device Class
- Class II
- Regulation Number
- 888.3043
- Review Panel
- OR
- Submission Type
A spinal screw sleeve bone fixation device is intended to be implanted in conjunction with a non-resorbable, metallic bone screw where the screw has lost purchase due to loosening, backout, or breakage. The device fits between the screw threads and surrounding bone, and provides increased surface area to create an interference fit to restore stability of the implant construct.