Name: Predicase
Price: 199 USD

K-number	K111065
Device name	STRYKER (R) PATIENT SPECIFIC POLYMER IMPLANT
Applicant	Howmedica Osteonics Corp. Dba Stryker Orthopeadics
Product code	GWO
Device class	Class II
Decision date	Jul 14, 2011
Decision	Substantially Equivalent
Regulation	882.5320

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Source

View the full FDA submission: accessdata.fda.gov

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STRYKER (R) PATIENT SPECIFIC POLYMER IMPLANT

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