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FDA 510(k) Application Details - K143229
Device Classification Name
Screw, Fixation, Bone
More FDA Info for this Device
510(K) Number
K143229
Device Name
Screw, Fixation, Bone
Applicant
NOVASTEP
Espace performance Alphasis - Batiment C1-C2
Saint Gregoire 35769 FR
Other 510(k) Applications for this Company
Contact
Gilles Audic
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
11/10/2014
Decision Date
02/06/2015
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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