GMK Sphere & GMK SpheriKA Cementless
K-Number: K223548 · 2023-01-20
ApplicantMedacta International S.A.
Decision Date2023-01-20
Product CodeMBH
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
GMK Sphere & GMK SpheriKA Cementless is a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2023-01-20 under approval number K223548. The device is classified under product code MBH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the GMK Sphere & GMK SpheriKA Cementless?
GMK Sphere & GMK SpheriKA Cementless is a medical device that received FDA 510(k) clearance on 2023-01-20. It is manufactured by Medacta International S.A.. The 510(k) number is K223548.
When was GMK Sphere & GMK SpheriKA Cementless approved by the FDA?
GMK Sphere & GMK SpheriKA Cementless received FDA 510(k) clearance on 2023-01-20, under approval number K223548.
What company makes GMK Sphere & GMK SpheriKA Cementless?
GMK Sphere & GMK SpheriKA Cementless is manufactured by Medacta International S.A..
What is the FDA product code for GMK Sphere & GMK SpheriKA Cementless?
The FDA product code for GMK Sphere & GMK SpheriKA Cementless is MBH.
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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.