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FDA 510(k) Application Details - K152099
Device Classification Name
More FDA Info for this Device
510(K) Number
K152099
Device Name
Genesys Spine Apache« Anchored Cervical Interbody Fusion System
Applicant
GENESYS SPINE
1250 CAPITAL OF TEXAS HWY
BUILDING 3, SUITE 600
AUSTIN, TX 78746 US
Other 510(k) Applications for this Company
Contact
BEN KELLER
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
OVE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/28/2015
Decision Date
07/28/2016
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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