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FDA 510(k) Application Details - K063635
Device Classification Name
Screw, Fixation, Bone
More FDA Info for this Device
510(K) Number
K063635
Device Name
Screw, Fixation, Bone
Applicant
SMALL BONE INNOVATIONS, INC.
505 PARK AVENUE
14TH FLOOR
NEW YORK, NY 10022 US
Other 510(k) Applications for this Company
Contact
ROBERT HOEHN
Other 510(k) Applications for this Contact
Regulation Number
888.3040
More FDA Info for this Regulation Number
Classification Product Code
HWC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/06/2006
Decision Date
08/29/2007
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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