510(k) K103068

KING COBRA ANTERIOR CERVICAL PLATE by Eminent Spine — Product Code KWQ

K103068 is an FDA 510(k) premarket notification submitted by Eminent Spine for the device "KING COBRA ANTERIOR CERVICAL PLATE". The FDA issued a decision of Substantially Equivalent on January 14, 2011. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Eminent Spine has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 2011
Date Received
October 18, 2010
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