Name: Predicase
Price: 199 USD

K-number	K161668
Device name	ConforMIS iTotal(R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS)
Applicant	Conformis, Inc.
Product code	JWH
Device class	Class II
Decision date	Jul 15, 2016
Decision	Substantially Equivalent
Regulation	888.3560

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Source

View the full FDA submission: accessdata.fda.gov

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ConforMIS iTotal(R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS)

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