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FDA 510(k) Application Details - K151708
Device Classification Name
Screw, Fixation, Bone
More FDA Info for this Device
510(K) Number
K151708
Device Name
Screw, Fixation, Bone
Applicant
NORMED MEDIZIN-TECHNIK GMBH
ULRICHSTRASSE 7
TUTTLINGEN D-78532 DE
Other 510(k) Applications for this Company
Contact
ARNE BRIEST
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
06/24/2015
Decision Date
03/02/2016
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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