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FDA 510(k) Application Details - K062734
Device Classification Name
Staple, Fixation, Bone
More FDA Info for this Device
510(K) Number
K062734
Device Name
Staple, Fixation, Bone
Applicant
VALPO ORTHOPEDIC TECHNOLOGY, INC.
4805 LAKERIDGE CT.
VALPARAISO, IN 46383 US
Other 510(k) Applications for this Company
Contact
RON CLARK
Other 510(k) Applications for this Contact
Regulation Number
888.3030
More FDA Info for this Regulation Number
Classification Product Code
JDR
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/13/2006
Decision Date
11/22/2006
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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