Amedica Valeo II Interbody Fusion Device

Intervertebral Fusion Device With Bone Graft, Lumbar

Amedica Corp

The following data is part of a premarket notification filed by Amedica Corp with the FDA for Amedica Valeo Ii Interbody Fusion Device.

Pre-market Notification Details

Device IDK142347
510k NumberK142347
Device Name:Amedica Valeo II Interbody Fusion Device
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant Amedica Corp 1885 West 2100 South Salt Lake City,  UT  84119
ContactWilliam D Jordan
CorrespondentWilliam D Jordan
Amedica Corp 1885 West 2100 South Salt Lake City,  UT  84119
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-08-22
Decision Date2014-11-18
Summary:summary

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