VAULT ALIF SYSTEM

Intervertebral Fusion Device With Integrated Fixation, Lumbar

SPINAL USA

The following data is part of a premarket notification filed by Spinal Usa with the FDA for Vault Alif System.

Pre-market Notification Details

Device IDK130445
510k NumberK130445
Device Name:VAULT ALIF SYSTEM
ClassificationIntervertebral Fusion Device With Integrated Fixation, Lumbar
Applicant SPINAL USA 1001 OAKWOOD BLVD Round Rock,  TX  78681
ContactJ.d. Webb
CorrespondentJ.d. Webb
SPINAL USA 1001 OAKWOOD BLVD Round Rock,  TX  78681
Product CodeOVD  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-02-21
Decision Date2013-04-25
Summary:summary

NIH GUDID Devices

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