K-number	K223708
Device name	Entasis 3D Dual-Lead Sacroiliac Implant System
Applicant	Corelink, LLC
Product code	OUR
Device class	Class II
Decision date	Mar 21, 2023
Decision	Substantially Equivalent
Regulation	888.3040

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Source

View the full FDA submission: accessdata.fda.gov

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Entasis 3D Dual-Lead Sacroiliac Implant System

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