Name: Predicase
Price: 199 USD

K-number	K212411
Device name	Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS)
Applicant	Conformis, Inc.
Product code	JWH
Device class	Class II
Decision date	Sep 23, 2021
Decision	Substantially Equivalent
Regulation	888.3560

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Source

View the full FDA submission: accessdata.fda.gov

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Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS)

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