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FDA 510(k) Application Details - K230716
Device Classification Name
Orthopedic Stereotaxic Instrument
More FDA Info for this Device
510(K) Number
K230716
Device Name
Orthopedic Stereotaxic Instrument
Applicant
Medtronic Sofamor Danek Inc
2600 Sofamor Danek Drive
Memphis, TN 38132 US
Other 510(k) Applications for this Company
Contact
Diamond Wallace
Other 510(k) Applications for this Contact
Regulation Number
882.4560
More FDA Info for this Regulation Number
Classification Product Code
OLO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/15/2023
Decision Date
07/18/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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