K-number	K210809
Device name	iTotal® Identity Cruciate Retaining (CR) Knee Replacement System (KRS)
Applicant	Conformis, Inc.
Product code	JWH
Device class	Class II
Decision date	May 12, 2021
Decision	Substantially Equivalent
Regulation	888.3560

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Source

View the full FDA submission: accessdata.fda.gov

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iTotal® Identity Cruciate Retaining (CR) Knee Replacement System (KRS)

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iTotal® Identity Cruciate Retaining (CR) Knee Replacement System (KRS)