Calibrate LTX 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 Calibrate Ltx Interbody System.

Pre-market Notification Details

Device IDK222455
510k NumberK222455
Device Name:Calibrate LTX Interbody System
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant Alphatec Spine, Inc. 1950 Camino Vida Roble Carlsbad,  CA  92008
ContactCynthia Dorne
CorrespondentCynthia Dorne
Alphatec Spine, Inc. 1950 Camino Vida Roble Carlsbad,  CA  92008
Product CodeMAX  
Subsequent Product CodeOVD
Subsequent Product CodePHM
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-08-15
Decision Date2022-11-18

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