Name: Predicase
Price: 199 USD

K-number	K140324
Device name	RIGIDLOOP ADJUSTABLE CORTICAL IMPLANT: STANDARD, LONG AND XL
Applicant	Depuy Mitek, A Johnson and Johnson Company
Product code	MBI
Device class	Class II
Decision date	Jul 7, 2014
Decision	Substantially Equivalent
Regulation	888.3040

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Source

View the full FDA submission: accessdata.fda.gov

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RIGIDLOOP ADJUSTABLE CORTICAL IMPLANT: STANDARD, LONG AND XL

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