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FDA 510(k) Application Details - K161303
Device Classification Name
Plate, Fixation, Bone
More FDA Info for this Device
510(K) Number
K161303
Device Name
Plate, Fixation, Bone
Applicant
MX ORTHOPEDICS, CORP.
1050 WALTHAM STREET
Suite 510
LEXINGTON, MA 02421 US
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Contact
Howard L. Schrayer
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
05/10/2016
Decision Date
01/26/2017
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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