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Fixture Removal Trephine and Guide Sleeve Kit 17 mm

Integrum AB · Model 2538 · UDI-DI 07340152101686

PJY Prescription

510(k) clearances

285

Adverse events (1 deaths)

Recalls

Facilities

Description

The fixture removal Trephine is a single use instrument used as a cutting tool that drills (cuts) into the bone around and along the Fixture to enable extraction of the Fixture. The Guide Sleeves are single use instruments. They are used together with the set of guide pins to centre the Trephine around the Fixture when the trephine cuts along the Fixture in the bone.

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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.