FFX Facet Fixation System— 510(k) K252153

Substantially Equivalent

Sc Medica

FDA 510(k) clearance K252153 for FFX Facet Fixation System, Substantially Equivalent on 2025-10-16. Applicant: Sc Medica. Device class: Unclassified.

Clearance details

Applicant: Sc Medica
Product code: Code MRW
Device class: Unclassified
Advisory panel: Unknown
Date received: 2025-07-09
Decision date: 2025-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Strasbourg, FR

Download summary PDF View on FDA.gov ↗

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K250679 — FFX Facet Fixation System2025-12-04

More clearances from Sc Medica

K232468 — SC Medica FFX2024-05-09

Data sourced from openFDA. This site is unofficial and independent of the FDA.