IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™ PEEK Interbody System, Transcend™ NanoTec™ Interbody System, IdentiTi™ ALIF Standalone Interbody System, IdentiTi™ NanoTec™ ALIF Standalone Interbody System, Identi

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, Identiti™ Nanotec™ Interbody System, Transcend™ Peek Interbody System, Transcend™ Nanotec™ Interbody System, Identiti™ Alif Standalone Interbody System, Identiti™ Nanotec™ Alif Standalone Interbody System, Identi.

Pre-market Notification Details

Device IDK220782
510k NumberK220782
Device Name:IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™ PEEK Interbody System, Transcend™ NanoTec™ Interbody System, IdentiTi™ ALIF Standalone Interbody System, IdentiTi™ NanoTec™ ALIF Standalone Interbody System, Identi
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
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 CodeMAX  
Subsequent Product CodeOVD
Subsequent Product CodeOVE
Subsequent Product CodePHM
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-17
Decision Date2022-06-09

Trademark Results [IdentiTi]

Mark Image

Registration | Serial
Company
Trademark
Application Date
IDENTITI
IDENTITI
88469099 not registered Live/Pending
Identiti Resources, Ltd.
2019-06-11
IDENTITI
IDENTITI
77343392 3556238 Live/Registered
ISON DISTRIBUTION, LTD
2007-12-04

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