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FDA 510(k) Application Details - K090983
Device Classification Name
Plate, Fixation, Bone
More FDA Info for this Device
510(K) Number
K090983
Device Name
Plate, Fixation, Bone
Applicant
MEDARTIS AG
11234 EL CAMINO REAL, STE 200
SAN DIEGO, CA 92130 US
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Contact
KEVIN A THOMAS
Other 510(k) Applications for this Contact
Regulation Number
888.3030
More FDA Info for this Regulation Number
Classification Product Code
HRS
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More FDA Info for this Product Code
Date Received
04/07/2009
Decision Date
07/01/2009
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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