Name: Predicase
Price: 199 USD

K-number	K211805
Device name	IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec Interbody System, Transcend NanoTec Interbody System
Applicant	Alphatec Spine, Inc.
Product code	MAX
Device class	Class II
Decision date	Sep 22, 2021
Decision	Substantially Equivalent
Regulation	888.3080

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Source

View the full FDA submission: accessdata.fda.gov

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IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec Interbody System, Transcend NanoTec Interbody System

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