510(k) DEN180065
DEN180065 is an FDA 510(k) premarket notification submitted by Woven Orthopedic Technologies, LLC for the device "OGmend Implant System". The FDA issued a decision of De Novo Granted on May 1, 2020. The device falls under product code QAC (Screw Sleeve Bone Fixation Device), a Class II device regulated under 21 CFR 888.3043. Woven Orthopedic Technologies, LLC has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- May 1, 2020
- Date Received
- December 13, 2018
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Screw Sleeve Bone Fixation Device
- Device Class
- Class II
- Regulation Number
- 888.3043
- Review Panel
- OR
- Submission Type
A 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.