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FDA 510(k)

Smart SPACE Shoulder Planner and 3D Positioners

K-Number: K222405 · 2022-12-20

ApplicantLima Corporate S.P.A.
Decision Date2022-12-20
Product CodeQHE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Smart SPACE Shoulder Planner and 3D Positioners is a medical device manufactured by Lima Corporate S.P.A.. It received FDA 510(k) clearance on 2022-12-20 under approval number K222405. The device is classified under product code QHE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Smart SPACE Shoulder Planner and 3D Positioners?

Smart SPACE Shoulder Planner and 3D Positioners is a medical device that received FDA 510(k) clearance on 2022-12-20. It is manufactured by Lima Corporate S.P.A.. The 510(k) number is K222405.

When was Smart SPACE Shoulder Planner and 3D Positioners approved by the FDA?

Smart SPACE Shoulder Planner and 3D Positioners received FDA 510(k) clearance on 2022-12-20, under approval number K222405.

What company makes Smart SPACE Shoulder Planner and 3D Positioners?

Smart SPACE Shoulder Planner and 3D Positioners is manufactured by Lima Corporate S.P.A..

What is the FDA product code for Smart SPACE Shoulder Planner and 3D Positioners?

The FDA product code for Smart SPACE Shoulder Planner and 3D Positioners is QHE.

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Related Devices (Code: QHE)

K192074Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas) K202454Smart SPACE Shoulder SystemTechmah Medical, LLC K200615Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas) K193560Materialise Shoulder Guide and Models, Materialise SurgiCase Shoulder Planner, Materialise Shoulder Planner, SurgiCase Shoulder Planner, SurgiCase PlannerMaterialise NV K212560Signature™ ONE SystemOrthosoft Inc (D/B/A Zimmer Cas) K202151Smart SPACE Shoulder SystemTechmah Medical, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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