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FDA 510(k)

CustomSurg OrthoPlanner

K-Number: K251863 · 2025-07-07

ApplicantCustomsurg AG
Decision Date2025-07-07
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CustomSurg OrthoPlanner is a medical device manufactured by Customsurg AG. It received FDA 510(k) clearance on 2025-07-07 under approval number K251863. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CustomSurg OrthoPlanner?

CustomSurg OrthoPlanner is a medical device that received FDA 510(k) clearance on 2025-07-07. It is manufactured by Customsurg AG. The 510(k) number is K251863.

When was CustomSurg OrthoPlanner approved by the FDA?

CustomSurg OrthoPlanner received FDA 510(k) clearance on 2025-07-07, under approval number K251863.

What company makes CustomSurg OrthoPlanner?

CustomSurg OrthoPlanner is manufactured by Customsurg AG.

What is the FDA product code for CustomSurg OrthoPlanner?

The FDA product code for CustomSurg OrthoPlanner is LLZ.

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Official Source

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