Name: Predicase
Price: 199 USD

K-number	K103010
Device name	STRYKER PATIENT SPECIFIC POLYMER IMPLANT
Applicant	Howmedica Osteonics Corp., Dba Stryker Orthopaedics
Product code	KKY
Device class	Class II
Decision date	Oct 26, 2010
Decision	Substantially Equivalent
Regulation	878.3500

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Source

View the full FDA submission: accessdata.fda.gov

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STRYKER PATIENT SPECIFIC POLYMER IMPLANT

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