Name: Predicase
Price: 199 USD

K-number	K063497
Device name	MODIFICATION TO SCANDIUS TRITIS ABSORBABLE TIBIAL RECONSTRUCTION SYSTEM
Applicant	Scandius Biomedical, Inc.
Product code	MAI
Device class	Class II
Decision date	Dec 19, 2006
Decision	Substantially Equivalent
Regulation	888.3030

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Source

View the full FDA submission: accessdata.fda.gov

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MODIFICATION TO SCANDIUS TRITIS ABSORBABLE TIBIAL RECONSTRUCTION SYSTEM

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