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FDA 510(k) Application Details - K071927
Device Classification Name
Cement, Bone, Vertebroplasty
More FDA Info for this Device
510(K) Number
K071927
Device Name
Cement, Bone, Vertebroplasty
Applicant
DEPUY SPINE, A JOHNSON & JOHNSON COMPANY
325 Paramount Drive
Raynham, MA 02767 US
Other 510(k) Applications for this Company
Contact
SHARON STAROWICZ
Other 510(k) Applications for this Contact
Regulation Number
888.3027
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Classification Product Code
NDN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/12/2007
Decision Date
11/21/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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