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FDA 510(k) Application Details - K042415
Device Classification Name
Cement, Bone, Vertebroplasty
More FDA Info for this Device
510(K) Number
K042415
Device Name
Cement, Bone, Vertebroplasty
Applicant
TECRES SPA
ONE DEMOCRACY PLAZA
6701 DEMOCRACY BLVD. STE. 700
BETHESDA, MD 20817 US
Other 510(k) Applications for this Company
Contact
CHRISTINE BRAUER
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
09/07/2004
Decision Date
06/09/2005
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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