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Instrument Kit: Fractured Abutment/ Screw USA

Integrum AB · Model 2533 · UDI-DI 07340152102027

PJY Prescription

510(k) clearances

285

Adverse events (1 deaths)

Recalls

Facilities

Description

The intended purpose of the Fractured Abutment / Abutment Screw kit is, by an Integrum certified physician to perform extraction of a fractured Abutment remnant in the Fixture of the OPRA™ Implant, and the extraction of a femur fractured Abutment Screw when the fracture has occurred in one of the threads of the OPRA™ Implant Abutment screw. T-Handle 5mm Socket M9 Guide Pin Rescue Drill Bit Holder Drill / Torx Guide Allen Key 2.5 mm

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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.