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FDA 510(k) Application Details - K150582
Device Classification Name
Cement, Bone, Vertebroplasty
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510(K) Number
K150582
Device Name
Cement, Bone, Vertebroplasty
Applicant
STRYKER CORPORATION
4100 E. MILHAM AVENUE
KALAMAZOO, MI 49001 US
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Contact
KRISTI ASHTON
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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
03/09/2015
Decision Date
06/12/2015
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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