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FDA 510(k) Application Details - K161894
Device Classification Name
Screw, Fixation, Bone
More FDA Info for this Device
510(K) Number
K161894
Device Name
Screw, Fixation, Bone
Applicant
SURGTECH INC
24600 CENTER RIDGE ROAD, SUITE 195,
WESTLAKE, OH 44145 US
Other 510(k) Applications for this Company
Contact
XUEGONG YU
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
07/11/2016
Decision Date
02/21/2017
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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