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Ogmend®

WOVEN ORTHOPEDIC TECHNOLOGIES LLC · Model 50-1003 · UDI-DI 00810050690027

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

Description

The Ogmend® Inserter Instrument or Inserter is a single use Class I Medical Device tool used to insert the Ogmend® Implant into a prepared bone hole during a given procedure. The inserter is a simple rod fabricated from passivated 304 stainless steel (full hard/spring temper) and is 8.0 inches in length, 0.080 inches in diameter with rounded edges on each end. The Inserter is used in conjunction with either size of the Ogmend® Sleeve (Medium & Large) to place the respective sleeve into a prepared bone hole.

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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.