K-number	K200097
Device name	Response BandLoc Spinal Fixation
Applicant	OrthoPediatrics Corp.
Product code	OWI
Device class	Class II
Decision date	Mar 16, 2020
Decision	Substantially Equivalent
Regulation	888.3010

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Source

View the full FDA submission: accessdata.fda.gov

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Response BandLoc Spinal Fixation

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