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FDA 510(k) Application Details - K152041
Device Classification Name
Orthopedic Stereotaxic Instrument
More FDA Info for this Device
510(K) Number
K152041
Device Name
Orthopedic Stereotaxic Instrument
Applicant
Mazor Robotics Ltd.
PO Box 3104, 7 HaEshel St.
Caesarea Park South 3088900 IL
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Contact
Ayelet Matia
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
07/22/2015
Decision Date
11/17/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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