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FDA 510(k) Application Details - K161478
Device Classification Name
Orthosis, Cervical Pedicle Screw Spinal Fixation
More FDA Info for this Device
510(K) Number
K161478
Device Name
Orthosis, Cervical Pedicle Screw Spinal Fixation
Applicant
Xenco Medical, LLC
9930 Mesa Rim Road
San Diego, CA 92121 US
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Contact
Gustavo Prado
Other 510(k) Applications for this Contact
Regulation Number
000.0000
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Classification Product Code
NKG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/31/2016
Decision Date
09/06/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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