Name: Predicase
Price: 199 USD

K-number	K010361
Device name	MEDTRONIC PS MEDICAL INVISX CRANIAL FIXATION SYSTEM, MODEL 60100-60900
Applicant	Medtronic PS Medical
Product code	GXR
Device class	Class II
Decision date	May 7, 2001
Decision	Substantially Equivalent
Regulation	882.5250

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Source

View the full FDA submission: accessdata.fda.gov

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MEDTRONIC PS MEDICAL INVISX CRANIAL FIXATION SYSTEM, MODEL 60100-60900

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