Name: Predicase
Price: 199 USD

K-number	K212245
Device name	Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument Selection, Fluoro 3D, Registration Software Fluoro 3D, Registration Software Paired Point, Registration Software Spine Surface Matching, Spine Planning, Elements Screw Planning Spine, Elements Spine Screw Planning
Applicant	Brainlab AG
Product code	OLO
Device class	Class II
Decision date	Apr 13, 2022
Decision	Substantially Equivalent
Regulation	882.4560

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Source

View the full FDA submission: accessdata.fda.gov

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Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument Selection, Fluoro 3D, Registration Software Fluoro 3D, Registration Software Paired Point, Registration Software Spine Surface Matching, Spine Planning, Elements Screw Planning Spine, Elements Spine Screw Planning

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