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FDA 510(k) Application Details - K080280
Device Classification Name
Screw, Fixation, Bone
More FDA Info for this Device
510(K) Number
K080280
Device Name
Screw, Fixation, Bone
Applicant
INSTRATEK, INC.
210 SPRING HILL DR.
SUITE 130
THE WOODLANDS, TX 77386 US
Other 510(k) Applications for this Company
Contact
Jeff Seavey
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
02/04/2008
Decision Date
03/14/2008
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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