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FDA 510(k) Application Details - K130008
Device Classification Name
Plate, Fixation, Bone
More FDA Info for this Device
510(K) Number
K130008
Device Name
Plate, Fixation, Bone
Applicant
I.T.S. GMBH
3150 E. 200TH STREET
PRIOR LAKE, MN 55372 US
Other 510(k) Applications for this Company
Contact
AL LIPPINCOTT
Other 510(k) Applications for this Contact
Regulation Number
888.3030
More FDA Info for this Regulation Number
Classification Product Code
HRS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/02/2013
Decision Date
06/25/2013
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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