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FDA 510(k)

MySpine WebPlanner

K-Number: K243697 · 2025-04-23

ApplicantMedacta International S.A.
Decision Date2025-04-23
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MySpine WebPlanner is the device name listed in this FDA 510(k) record. The listed applicant is Medacta International S.A.. It received FDA 510(k) clearance on 2025-04-23 under 510(k) number K243697. 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 MySpine WebPlanner?

MySpine WebPlanner is a medical device that received FDA 510(k) clearance on 2025-04-23. The listed applicant is Medacta International S.A.. The 510(k) number is K243697.

When did MySpine WebPlanner receive FDA 510(k) clearance?

MySpine WebPlanner received FDA 510(k) clearance on 2025-04-23, under 510(k) number K243697.

Who is the listed applicant for MySpine WebPlanner?

The FDA 510(k) record lists Medacta International S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MySpine WebPlanner?

The FDA product code for MySpine WebPlanner is LLZ.

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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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