Name: Predicase
Price: 199 USD

K-number	K161366
Device name	ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS)
Applicant	Conformis, Inc.
Product code	JWH
Device class	Class II
Decision date	Jun 14, 2016
Decision	Substantially Equivalent
Regulation	888.3560

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Source

View the full FDA submission: accessdata.fda.gov

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ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS)

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