FDA 510(k) Application Details - K171628

Device Classification Name	Screw, Fixation, Bone   More FDA Info for this Device
510(K) Number	K171628
Device Name	Screw, Fixation, Bone
Applicant	Stuckenbrock Medizintechnik GmbH Lessingstra▀e 50 Tuttlingen d-78532 DE Other 510(k) Applications for this Company
Contact	Fabian Stuckenbrock 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	06/02/2017
Decision Date	01/12/2018
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