Name: Predicase
Price: 199 USD

K-number	K213389
Device name	Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint Posterior Stabilized (PS) Knee Replacement System
Applicant	Conformis, Inc.
Product code	JWH
Device class	Class II
Decision date	Nov 10, 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 Cruciate Retaining (CR) Knee Replacement System and Identity Imprint Posterior Stabilized (PS) Knee Replacement System

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