Smart SPACE Shoulder Planner and 3D Positioners— 510(k) K222405

Name: FDA 510(k) clearance K222405
Creator: U.S. Food and Drug Administration
Published: 2022-12-20

Substantially Equivalent

Lima Corporate S.P.A.

FDA 510(k) clearance K222405 for Smart SPACE Shoulder Planner and 3D Positioners, Substantially Equivalent on 2022-12-20. Applicant: Lima Corporate S.P.A.. Device class: 2.

Clearance details

Applicant: Lima Corporate S.P.A.
Product code: Code QHE
Device class: Class 2
Regulation: 21 CFR 888.3660
Advisory panel: Orthopedic
Date received: 2022-08-09
Decision date: 2022-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Villanova Di San Daniele Del Friuli, IT

Download summary PDF View on FDA.gov ↗

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