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FDA 510(k) Application Details - K143028
Device Classification Name
Appliance, Fixation, Spinal Intervertebral Body
More FDA Info for this Device
510(K) Number
K143028
Device Name
Appliance, Fixation, Spinal Intervertebral Body
Applicant
ORTHOFIX, INC.
3451 PLANO PARKWAY
LEWISVILLE, TX 75056 US
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Contact
Natalia Volosen
Other 510(k) Applications for this Contact
Regulation Number
888.3060
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Classification Product Code
KWQ
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More FDA Info for this Product Code
Date Received
10/21/2014
Decision Date
05/29/2015
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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