Amedica (AMDA) Receives FDA 510(k) Premarket Notification for Valeo II Interbody Fusion Device System

August 22, 2016 3:34 PM EDT
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Amedica (NASDAQ: AMDA) active amid FDA 510(k) premarket notification for its Intervertebral Fusion Device With Bone Graft.

The following was posted to the FDA website on Monday:

Device Classification NameIntervertebral Fusion Device With Bone Graft, Lumbar
510(K) NumberK161405
Device NameValeo II Interbody Fusion Device System
1885 West 2100 South
Salt Lake City, UT 84119
Applicant ContactWilliam D. Jordan
CorrespondentAMEDICA CORP.
1885 West 2100 South
Salt Lake City, UT 84119
Correspodent ContactWilliam D. Jordan
Regulation Number888.308
Classification Product CodeMAX
Subsequent Product CodeODP
Date Received5/20/2016
Decision Date8/19/2016
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
510k Review PanelOrthopedic
Reviewed By Third PartyNo
Combination ProductNo

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