K-number	K203780
Device name	Harvester SI: Sacroiliac Fixation System
Applicant	Spinus International, Inc.
Product code	OUR
Device class	Class II
Decision date	Mar 23, 2021
Decision	Substantially Equivalent
Regulation	888.3040

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Source

View the full FDA submission: accessdata.fda.gov

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Harvester SI: Sacroiliac Fixation System

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