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FDA 510(k) Application Details - K160713
Device Classification Name
Orthopedic Stereotaxic Instrument
More FDA Info for this Device
510(K) Number
K160713
Device Name
Orthopedic Stereotaxic Instrument
Applicant
MEDTRONIC POWERED SURGICAL SOLUTIONS
4620 NORTH BEACH ST.
FORT WORTH, TX 76137 US
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DEEP PAL
Other 510(k) Applications for this Contact
Regulation Number
882.4560
More FDA Info for this Regulation Number
Classification Product Code
OLO
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More FDA Info for this Product Code
Date Received
03/15/2016
Decision Date
05/26/2016
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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