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FDA 510(k) Application Details - K161129
Device Classification Name
More FDA Info for this Device
510(K) Number
K161129
Device Name
PILLAR SA PTC
Applicant
ORTHOFIX INC.
3451 PLANO PARKWAY
LEWISVILLE, TX 75056 US
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Contact
Natalia Volosen
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Regulation Number
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Classification Product Code
OVD
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Date Received
04/21/2016
Decision Date
09/08/2016
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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