IdentiTi And Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System, IdentiTi NanoTec Cervical Interbody System, Transcend Cervical PEEK Interbody System, Transcend NanoTec Cervical Interbody System, IdentiTi Cervical Standalone I

Intervertebral Fusion Device With Bone Graft, Cervical

Alphatec Spine Inc.

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

Pre-market Notification Details

Device IDK222973
510k NumberK222973
Device Name:IdentiTi And Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System, IdentiTi NanoTec Cervical Interbody System, Transcend Cervical PEEK Interbody System, Transcend NanoTec Cervical Interbody System, IdentiTi Cervical Standalone I
ClassificationIntervertebral Fusion Device With Bone Graft, Cervical
Applicant Alphatec Spine Inc. 1950 Camino Vida Roble Carlsbad,  CA  92008
ContactAndrew Zhang
CorrespondentAndrew Zhang
Alphatec Spine Inc. 1950 Camino Vida Roble Carlsbad,  CA  92008
Product CodeODP  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-09-28
Decision Date2022-11-17

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