K-number	K223548
Device name	GMK Sphere & GMK SpheriKA Cementless
Applicant	Medacta International S.A.
Product code	MBH
Device class	Class II
Decision date	Jan 20, 2023
Decision	Substantially Equivalent
Regulation	888.3565

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Source

View the full FDA submission: accessdata.fda.gov

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GMK Sphere & GMK SpheriKA Cementless

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