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510(k) K233223

OGmend® Implant Enhancement System by Woven Orthopedic Technologies — Product Code QVI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 2023
Date Received
September 28, 2023
Clearance Type
Special
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.

Other clearances by Woven Orthopedic Technologies

  • K223075 — Ogmend® Implant Enhancement System (February 27, 2023)
  • DEN180065 — OGmend Implant System (May 1, 2020)

Other clearances for product code QVI

  • K223075 — Ogmend® Implant Enhancement System (February 27, 2023)