Archer PSI System— 510(k) K243509

Substantially Equivalent

3D-Side

FDA 510(k) clearance K243509 for Archer PSI System, Substantially Equivalent on 2025-05-12. Applicant: 3D-Side.

Clearance details

Applicant: 3D-Side
Product code: Code QHE
Advisory panel: Orthopedic
Date received: 2024-11-12
Decision date: 2025-05-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mont-Saint-Guibert, BE

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