ARVIS Surgical Navigation System— 510(k) K243980

Substantially Equivalent

Kico Knee Innovation Company Pty Limited

FDA 510(k) clearance K243980 for ARVIS Surgical Navigation System, Substantially Equivalent on 2025-03-21. Applicant: Kico Knee Innovation Company Pty Limited.

Clearance details

Applicant: Kico Knee Innovation Company Pty Limited
Product code: Code SBF
Advisory panel: Neurology
Date received: 2024-12-23
Decision date: 2025-03-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Frenchs Forest, AU

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