K-number	K133082
Device name	OSTEOSYMBIONICS PATIENT-SPECIFIC CRANIAL PLATE
Applicant	Osteosymbionics, LLC
Product code	GXN
Device class	Class II
Decision date	May 20, 2014
Decision	Substantially Equivalent
Regulation	882.5330

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View the full FDA submission: accessdata.fda.gov

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OSTEOSYMBIONICS PATIENT-SPECIFIC CRANIAL PLATE

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