Name: Predicase
Price: 199 USD

K-number	K083009
Device name	ORTHO-MAP-ONCOLOGY NAVIGATION SOFTWARE, MODELS 6005-650-000, 6005-651-000
Applicant	Stryker Leibinger GmbH & Co KG
Product code	OLO
Device class	Class II
Decision date	Feb 19, 2009
Decision	Substantially Equivalent
Regulation	882.4560

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Source

View the full FDA submission: accessdata.fda.gov

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ORTHO-MAP-ONCOLOGY NAVIGATION SOFTWARE, MODELS 6005-650-000, 6005-651-000

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