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FDA 510(k) Application Details - K153207
Device Classification Name
Plate, Fixation, Bone
More FDA Info for this Device
510(K) Number
K153207
Device Name
Plate, Fixation, Bone
Applicant
Additive Orthopaedics, LLC
83 Amelia Circle
Little Silver, NJ 07739 US
Other 510(k) Applications for this Company
Contact
GREGORY KOWALCZYK
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
11/05/2015
Decision Date
09/07/2016
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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