Name: Predicase
Price: 199 USD

K-number	K111492
Device name	ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER MODEL 2.5, ZIMMER PATIENT SPECIFIC INSTRUMENTS
Applicant	Materialise NV
Product code	JWH
Device class	Class II
Decision date	Oct 13, 2011
Decision	Substantially Equivalent
Regulation	888.3560

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Source

View the full FDA submission: accessdata.fda.gov

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ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER MODEL 2.5, ZIMMER PATIENT SPECIFIC INSTRUMENTS

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