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FDA 510(k) Application Details - K163301
Device Classification Name
Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
More FDA Info for this Device
510(K) Number
K163301
Device Name
Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
Applicant
Medtronic Sofamor Danek USA, Inc.
1800 Pyramid Place
Memphis, TN 38132 US
Other 510(k) Applications for this Company
Contact
Justin O'Connor
Other 510(k) Applications for this Contact
Regulation Number
888.3070
More FDA Info for this Regulation Number
Classification Product Code
NKB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/22/2016
Decision Date
12/20/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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