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FDA 510(k) Application Details - K152145
Device Classification Name
Plate, Fixation, Bone
More FDA Info for this Device
510(K) Number
K152145
Device Name
Plate, Fixation, Bone
Applicant
OSTEOMED
3885 Arapaho Rd
ADDISON, TX 75001 US
Other 510(k) Applications for this Company
Contact
Piedad Pena
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
08/03/2015
Decision Date
12/21/2015
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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