GMK Sphere
K-Number: K162035 · 2017-03-06
ApplicantMedacta International S.A.
Decision Date2017-03-06
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
GMK Sphere is a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2017-03-06 under approval number K162035. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the GMK Sphere?
GMK Sphere is a medical device that received FDA 510(k) clearance on 2017-03-06. It is manufactured by Medacta International S.A.. The 510(k) number is K162035.
When was GMK Sphere approved by the FDA?
GMK Sphere received FDA 510(k) clearance on 2017-03-06, under approval number K162035.
What company makes GMK Sphere?
GMK Sphere is manufactured by Medacta International S.A..
What is the FDA product code for GMK Sphere?
The FDA product code for GMK Sphere is JWH.
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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.