Name: Predicase
Price: 199 USD

K-number	K210035
Device name	ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix Anterior Cervical Plate System, Spinema Lumbar Plate System
Applicant	Aegis Spine
Product code	OUR
Device class	Class II
Decision date	Feb 16, 2021
Decision	Substantially Equivalent
Regulation	888.3040

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Source

View the full FDA submission: accessdata.fda.gov

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ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix Anterior Cervical Plate System, Spinema Lumbar Plate System

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