Name: Predicase
Price: 199 USD

K-number	K171893
Device name	Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone Synergy Cervical Interbody Fusion System (Slate)
Applicant	Bluestone Synergy
Product code	MAX
Device class	Class II
Decision date	Sep 8, 2017
Decision	Substantially Equivalent
Regulation	888.3080

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone Synergy Cervical Interbody Fusion System (Slate)

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