Name: Predicase
Price: 199 USD

K-number	K063052
Device name	LORENZ TITANIUM FRACTURE / RECONSTRUCTION DEVICES AND PRE-BENT PLATES
Applicant	Walter Lorenz Surgical, Inc.
Product code	JEY
Device class	Class II
Decision date	Jan 12, 2007
Decision	Substantially Equivalent
Regulation	872.4760

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Source

View the full FDA submission: accessdata.fda.gov

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LORENZ TITANIUM FRACTURE / RECONSTRUCTION DEVICES AND PRE-BENT PLATES

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