Name: Predicase
Price: 199 USD

K-number	K203447
Device name	iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity Posterior Stabilizing (PS) Total Knee Replacement
Applicant	Conformis, Inc.
Product code	JWH
Device class	Class II
Decision date	Dec 22, 2020
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) Total Knee Replacement, iTotal Identity Posterior Stabilizing (PS) Total Knee Replacement

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