K-number	K181635
Device name	GMK Sphere CR Tibial Inserts
Applicant	Medacta International S.A.
Product code	JWH
Device class	Class II
Decision date	Aug 23, 2018
Decision	Substantially Equivalent
Regulation	888.3560

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Source

View the full FDA submission: accessdata.fda.gov

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GMK Sphere CR Tibial Inserts

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