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. Device class: 2.

Clearance details

Applicant: 3D-Side
Product code: Code QHE
Device class: Class 2
Regulation: 21 CFR 888.3660
Advisory panel: Orthopedic
Date received: 2024-11-12
Decision date: 2025-05-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mont-Saint-Guibert, BE

Download summary PDF View on FDA.gov ↗

Recent devices under product code QHE

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K260104 — Signature ONE System2026-02-04
K251558 — Precision AI Surgical Planning System (PAI-SPS)2026-01-12
K241470 — CORE Shoulder System2025-02-20

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