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FDA 510(k) Application Details - K173372
Device Classification Name
Orthopedic Stereotaxic Instrument
More FDA Info for this Device
510(K) Number
K173372
Device Name
Orthopedic Stereotaxic Instrument
Applicant
Blue Ortho
6 Allee de Bethleem
Gieres 38610 FR
Other 510(k) Applications for this Company
Contact
Anthony Boyer
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
10/27/2017
Decision Date
11/24/2017
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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