Name: Predicase
Price: 199 USD

K-number	K214109
Device name	PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)
Applicant	Kontour(XiAn) Medical Technology Co., Ltd.
Product code	GXN
Device class	Class II
Decision date	Oct 28, 2022
Decision	Substantially Equivalent
Regulation	882.5330

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Source

View the full FDA submission: accessdata.fda.gov

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PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)

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