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FDA 510(k) Application Details - K091234
Device Classification Name
Cement, Bone, Vertebroplasty
More FDA Info for this Device
510(K) Number
K091234
Device Name
Cement, Bone, Vertebroplasty
Applicant
SKELTEX TECHNOLOGIES, INC.
75 DE MORTAGNE BLVD.
BOUCHERVILLE, QUEBEC J4B 6Y4 CA
Other 510(k) Applications for this Company
Contact
GEORGE PAPAGIANNIS
Other 510(k) Applications for this Contact
Regulation Number
888.3027
More FDA Info for this Regulation Number
Classification Product Code
NDN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/27/2009
Decision Date
02/16/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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