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 a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2021-07-23 under approval 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. It is manufactured by Medacta International S.A.. The 510(k) number is K211386.
When was MySpine WebPlanner & MyBalance approved by the FDA?
MySpine WebPlanner & MyBalance received FDA 510(k) clearance on 2021-07-23, under approval number K211386.
What company makes MySpine WebPlanner & MyBalance?
MySpine WebPlanner & MyBalance is manufactured by Medacta International S.A..
What is the FDA product code for MySpine WebPlanner & MyBalance?
The FDA product code for MySpine WebPlanner & MyBalance is LLZ.
Other Devices by Medacta International S.A.
Related Devices (Code: LLZ)
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.