Name: Predicase
Price: 199 USD

K-number	K090877
Device name	PROXIMAL TIBIA LOCKING PLATE STANDARD AND LARGE, 3.5MM LOW PROFILE AND MULTIDIRECTIONAL SCREWS
Applicant	DePuy Orthopaedics, Inc.
Product code	HRS
Device class	Class II
Decision date	Jun 26, 2009
Decision	Substantially Equivalent
Regulation	888.3030

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Source

View the full FDA submission: accessdata.fda.gov

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PROXIMAL TIBIA LOCKING PLATE STANDARD AND LARGE, 3.5MM LOW PROFILE AND MULTIDIRECTIONAL SCREWS

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