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FDA 510(k) Application Details - K123942
Device Classification Name
Cement, Bone, Vertebroplasty
More FDA Info for this Device
510(K) Number
K123942
Device Name
Cement, Bone, Vertebroplasty
Applicant
STRYKER CORPORATION
4100 E. MILHAM AVE
KALAMAZOO, MI 49001 US
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Contact
CHRISTINA MCKEE
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Regulation Number
888.3027
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Classification Product Code
NDN
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More FDA Info for this Product Code
Date Received
12/20/2012
Decision Date
04/03/2013
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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