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FDA 510(k) Application Details - K142053
Device Classification Name
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510(K) Number
K142053
Device Name
UNIVERSAL CLAMP SPINAL FIXATION SYSTEM
Applicant
ZIMMER SPINE, INC.
7375 BUSH LAKE RD.
MINNEAPOLIS, MN 55439 US
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HOLLY SEPPANEN
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Regulation Number
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Classification Product Code
OWI
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Date Received
07/29/2014
Decision Date
10/29/2014
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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