KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) System

Intervertebral Fusion Device With Integrated Fixation, Lumbar

Kyocera Medical Technologies, Inc.

The following data is part of a premarket notification filed by Kyocera Medical Technologies, Inc. with the FDA for Kmti Tesera Sa Anterior Lumbar Interbody Fusion (alif) System.

Pre-market Notification Details

Device IDK193320
510k NumberK193320
Device Name:KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) System
ClassificationIntervertebral Fusion Device With Integrated Fixation, Lumbar
Applicant Kyocera Medical Technologies, Inc. 1200 California St, Suite 210 Redlands,  CA  92374
ContactAnthony Debenedictis
CorrespondentSharyn Orton
MEDIcept, Inc. 200 Homer Ave Ashland,  MA  01721
Product CodeOVD  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
510k Review PanelOrthopedic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-02
Decision Date2020-02-04

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