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

Intervertebral Fusion Device With Bone Graft, Lumbar

Alphatec Spine, Inc.

The following data is part of a premarket notification filed by Alphatec Spine, Inc. with the FDA for Identiti Porous Ti Interbody System, Transcend Peek Interbody System, Identiti Nanotec Interbody System, Transcend Nanotec Interbody System.

Pre-market Notification Details

Device IDK211805
510k NumberK211805
Device Name:IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec Interbody System, Transcend NanoTec Interbody System
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant Alphatec Spine, Inc. 1950 Camino Vida Roble Carlsbad,  CA  92008
ContactSandy Gill
CorrespondentSandy Gill
Alphatec Spine, Inc. 1950 Camino Vida Roble Carlsbad,  CA  92008
Product CodeMAX  
Subsequent Product CodeODP
Subsequent Product CodeOVD
Subsequent Product CodePHM
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-11
Decision Date2021-09-22

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