K-number	K230850
Device name	United Orthopedic Knee Patient Specific Instrumentation
Applicant	Enhatch, Inc.
Product code	OOG
Device class	Class II
Decision date	Dec 20, 2023
Decision	Substantially Equivalent
Regulation	888.3560

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Source

View the full FDA submission: accessdata.fda.gov

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United Orthopedic Knee Patient Specific Instrumentation

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