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FDA 510(k) Application Details - K162419
Device Classification Name
More FDA Info for this Device
510(K) Number
K162419
Device Name
FIREFLY« Pedicle Screw Navigation Guide
Applicant
MIGHTY OAK MEDICAL INC.
750 W. HAMPDEN AVENUE
SUITE 120
Englewood, CO 80110 US
Other 510(k) Applications for this Company
Contact
Mark A. Wylie
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PQC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/30/2016
Decision Date
10/28/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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