GMK Sphere CR Tibial Inserts
K-Number: K181635 · 2018-08-23
ApplicantMedacta International S.A.
Decision Date2018-08-23
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
GMK Sphere CR Tibial Inserts is a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2018-08-23 under approval number K181635. 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 CR Tibial Inserts?
GMK Sphere CR Tibial Inserts is a medical device that received FDA 510(k) clearance on 2018-08-23. It is manufactured by Medacta International S.A.. The 510(k) number is K181635.
When was GMK Sphere CR Tibial Inserts approved by the FDA?
GMK Sphere CR Tibial Inserts received FDA 510(k) clearance on 2018-08-23, under approval number K181635.
What company makes GMK Sphere CR Tibial Inserts?
GMK Sphere CR Tibial Inserts is manufactured by Medacta International S.A..
What is the FDA product code for GMK Sphere CR Tibial Inserts?
The FDA product code for GMK Sphere CR Tibial Inserts 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.