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FDA 510(k) Application Details - K142594
Device Classification Name
Intervertebral Fusion Device With Bone Graft, Lumbar
More FDA Info for this Device
510(K) Number
K142594
Device Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant
NVISION BIOMEDICAL TECHNOLOGIES, LLC
18618 TUSCANY STONE SUITE 120
SAN ANTONIO, TN 78258 US
Other 510(k) Applications for this Company
Contact
Brian Kieser
Other 510(k) Applications for this Contact
Regulation Number
888.3080
More FDA Info for this Regulation Number
Classification Product Code
MAX
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More FDA Info for this Product Code
Date Received
09/15/2014
Decision Date
11/28/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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