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.
An implantable tube-like sleeve intended to provide a secure fixing for a bone screw (e.g. orthopaedic, spinal) which has lost purchase due to screw loosening, back out, or breakage. It is inserted into the screw hole so that when a screw is inserted, a mechanical wedge is created as it is tightened. The sleeve is made of a non-bioabsorbable polymer and sleeve size is adjusted/configured intraoperatively. Disposable devices associated with implantation may be supplied with the sleeve.
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