Name: Predicase
Price: 199 USD

K-number	K150928
Device name	Materialise TKA Guide System, Materialise TKA Planner, Materialise TKA Guides
Applicant	Materialise NV
Product code	JWH
Device class	Class II
Decision date	Aug 10, 2015
Decision	Substantially Equivalent
Regulation	888.3560

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Source

View the full FDA submission: accessdata.fda.gov

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Materialise TKA Guide System, Materialise TKA Planner, Materialise TKA Guides

Everything you need for a 510(k) submission. Nothing you don't.