Name: Predicase
Price: 199 USD

K-number	K192718
Device name	Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology
Applicant	Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.
Product code	MAX
Device class	Class II
Decision date	Dec 20, 2019
Decision	Substantially Equivalent
Regulation	888.3080

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Source

View the full FDA submission: accessdata.fda.gov

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Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology

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