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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
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