FDA 510(k)

CustomSurg OrthoPlanner

K-Number: K251863 · 2025-07-07

Decision Date2025-07-07

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

CustomSurg OrthoPlanner is the device name listed in this FDA 510(k) record. The listed applicant is Customsurg AG. It received FDA 510(k) clearance on 2025-07-07 under 510(k) 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. The listed applicant is Customsurg AG. The 510(k) number is K251863.

When did CustomSurg OrthoPlanner receive FDA 510(k) clearance?

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

Who is the listed applicant for CustomSurg OrthoPlanner?

The FDA 510(k) record lists Customsurg AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CustomSurg OrthoPlanner?

The FDA product code for CustomSurg OrthoPlanner is LLZ.

Related Devices (Code: LLZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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