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Ogmend®

WOVEN ORTHOPEDIC TECHNOLOGIES LLC · Model 32-6500M · UDI-DI 00810050690041

QVI Prescription
1
510(k) clearances
0
Adverse events
0
Recalls
3
Facilities

Description

The Ogmend® Implant consists of a sterile, single-use, permanently implanted sleeve intended to provide supplemental fixation to restore stability when the screw-to-bone interface becomes mechanically compromised. The Ogmend® Implant is manufactured from PET fibers and provides a helically braided structure that is captured by a screw when the screw is advanced during placement. When inserted into a prepared bone hole, the Ogmend® Implant is designed to use the principles of interference fit, surface area contact, and pressure distribution to secure the screw to the bone and achieve stability at the screw-to-bone interface allowing for subsequent tissue ingrowth to the screw root through the open, braided, mesh architecture. The Medum Ogmend® has an inner diameter of 6.5mm and an outer diameter of 7.5mm and can be used with screws ranging in diameter from 3.5mm to 6.5mm. Ogmend® Medium Sleeve is supplied at a length of 100mm and is cut intra-operatively to the appropriate length.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.