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FDA 510(k)

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 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 2023-01-20 under 510(k) 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. The listed applicant is Medacta International S.A.. The 510(k) number is K223548.

When did GMK Sphere & GMK SpheriKA Cementless receive FDA 510(k) clearance?

GMK Sphere & GMK SpheriKA Cementless received FDA 510(k) clearance on 2023-01-20, under 510(k) number K223548.

Who is the listed applicant for GMK Sphere & GMK SpheriKA Cementless?

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 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.

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