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FDA 510(k) Application Details - K132968
Device Classification Name
More FDA Info for this Device
510(K) Number
K132968
Device Name
UNIVISE SPINOUS PROCESS FIXATION PLATE (35MM, 40MM)
Applicant
STRYKER SPINE
2 PEARL COURT
ALLENDALE, NJ 07401 US
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Contact
KRISTEN MEANY, MS, CQA, RAC
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
PEK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/23/2013
Decision Date
11/18/2013
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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