510(k) K090415

EMINENT SPINE BUTTRESS (FANG) PLATE SYSTEM by Eminent Spine — Product Code KWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 2009
Date Received
February 18, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Spinal Intervertebral Body
Device Class
Class II
Regulation Number
888.3060
Review Panel
OR
Submission Type