Name: Predicase
Price: 199 USD

K-number	K214011
Device name	Catalyft PL Expandable Interbody System Navigated Instruments, Anteralign TL Spinal System with Titan nanoLOCK Surface Technology Navigated Instruments, and CD Horizon Solera Voyager Spinal System Navigated, Guided, and Powered Drivers
Applicant	Medtronic Sofamor Danek USA, Inc.
Product code	OLO
Device class	Class II
Decision date	Feb 9, 2022
Decision	Substantially Equivalent
Regulation	882.4560

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Source

View the full FDA submission: accessdata.fda.gov

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Catalyft PL Expandable Interbody System Navigated Instruments, Anteralign TL Spinal System with Titan nanoLOCK Surface Technology Navigated Instruments, and CD Horizon Solera Voyager Spinal System Navigated, Guided, and Powered Drivers

Everything you need for a 510(k) submission. Nothing you don't.

Catalyft PL Expandable Interbody System Navigated Instruments, Anteralign TL Spinal System with Titan nanoLOCK Surface Technology Navigated Instruments, and CD Horizon Solera Voyager Spinal System Navigated, Guided, and Powered Drivers