Tesera-k 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 Tesera-k Alif System.

Pre-market Notification Details

Device IDK212980
510k NumberK212980
Device Name:Tesera-k ALIF System
ClassificationIntervertebral Fusion Device With Integrated Fixation, Lumbar
Applicant Kyocera Medical Technologies, Inc. 1200 California Street, Ste. 210 Redlands,  CA  92374
ContactScott Rucker
CorrespondentNathan Wright
Empirical Testing Corp. 4628 Northpark Drive Colorado Springs,  CO  80918
Product CodeOVD  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-17
Decision Date2022-01-07

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