K-number	K210099
Device name	Meticuly Patient-Specific Titanium Mesh Implant
Applicant	Meticuly Co., Ltd.
Product code	GXN
Device class	Class II
Decision date	Dec 21, 2021
Decision	Substantially Equivalent
Regulation	882.5330

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Source

View the full FDA submission: accessdata.fda.gov

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Meticuly Patient-Specific Titanium Mesh Implant

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