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FDA 510(k) Application Details - K110348
Device Classification Name
More FDA Info for this Device
510(K) Number
K110348
Device Name
UNIVERSAL CLAMP SPINAL FIXATION SYSTEM
Applicant
ZIMMER SPINE
7375 BUSH LAKE ROAD
EDINA, MN 55439 US
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Contact
ELSA A LINKE
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Regulation Number
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Classification Product Code
OWI
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Date Received
02/07/2011
Decision Date
08/11/2011
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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