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FDA 510(k) Application Details - K192336
Device Classification Name
Orthopedic Stereotaxic Instrument
More FDA Info for this Device
510(K) Number
K192336
Device Name
Orthopedic Stereotaxic Instrument
Applicant
Medtronic Sofamor Danek USA, INC.
1800 Pyramid Place
Memphis, TN 38132 US
Other 510(k) Applications for this Company
Contact
Parwinder Singh
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
08/28/2019
Decision Date
11/22/2019
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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