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HEADFRAME PFK TYPE 1.1 FDA/ROW INTEGRA (FMI)

INSIGHTEC LTD · Model SET400168-AE PFK TYPE 1.1 FDA/ROW INTEGRA (FMI) · UDI-DI 07290019402466

POH Prescription

510(k) clearances

261

Adverse events (5 deaths)

Recalls

Facilities

Description

HEADFRAME PFK TYPE 1.1 FDA/ROW INTEGRA (FMI). Multi use Stereotactic Frame Set for fixing the skull position during neuro FUS clinical treatment. These are the upgrade kits for Integra headframes to allow compatibility with Insightec-made PFK

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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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.