K-number	K220357
Device name	MedCAD AccuShape Titanium Patient-Specific Cranial Implant
Applicant	Medcad
Product code	GXN
Device class	Class II
Decision date	Aug 26, 2022
Decision	Substantially Equivalent
Regulation	882.5330

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Source

View the full FDA submission: accessdata.fda.gov

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MedCAD AccuShape Titanium Patient-Specific Cranial Implant

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