Name: Predicase
Price: 199 USD

K-number	K162358
Device name	T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System
Applicant	Synthes USA Products, LLC
Product code	MAX
Device class	Class II
Decision date	Nov 1, 2016
Decision	Substantially Equivalent
Regulation	888.3080

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Source

View the full FDA submission: accessdata.fda.gov

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T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System

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