K-number	K211883
Device name	QUANTUM® Patient Specific Instrumentation (PSI) System
Applicant	In2bones Sas
Product code	HSN
Device class	Class II
Decision date	Aug 11, 2021
Decision	Substantially Equivalent
Regulation	888.3110

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Source

View the full FDA submission: accessdata.fda.gov

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QUANTUM® Patient Specific Instrumentation (PSI) System

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