K-number	K240199
Device name	IntraOp Alignment System
Applicant	Alphatec Spine, Inc.
Product code	OWB
Device class	Class II
Decision date	May 22, 2024
Decision	Substantially Equivalent
Regulation	892.1650

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Source

View the full FDA submission: accessdata.fda.gov

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IntraOp Alignment System

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