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FDA 510(k) Application Details - K163032
Device Classification Name
Cement, Bone, Vertebroplasty
More FDA Info for this Device
510(K) Number
K163032
Device Name
Cement, Bone, Vertebroplasty
Applicant
Medtronic Inc.
1800 Pyramid Place
Memphis, TN 38132 US
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Contact
Pamela Edwards
Other 510(k) Applications for this Contact
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
10/31/2016
Decision Date
02/27/2017
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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