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FDA 510(k)

MySpine WebPlanner & MyBalance

K-Number: K211386 · 2021-07-23

ApplicantMedacta International S.A.
Decision Date2021-07-23
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MySpine WebPlanner & MyBalance 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 2021-07-23 under 510(k) number K211386. 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 & MyBalance?

MySpine WebPlanner & MyBalance is a medical device that received FDA 510(k) clearance on 2021-07-23. The listed applicant is Medacta International S.A.. The 510(k) number is K211386.

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

MySpine WebPlanner & MyBalance received FDA 510(k) clearance on 2021-07-23, under 510(k) number K211386.

Who is the listed applicant for MySpine WebPlanner & MyBalance?

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 & MyBalance?

The FDA product code for MySpine WebPlanner & MyBalance 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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