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FDA 510(k) Application Details - K142271
Device Classification Name
More FDA Info for this Device
510(K) Number
K142271
Device Name
Zavation Z-Link Lumbar
Applicant
Zavation, LLC
400 Liberty Park
Flowood, MS 39232 US
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Contact
Lawrence Walker
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Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
OVD
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More FDA Info for this Product Code
Date Received
08/15/2014
Decision Date
12/19/2014
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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