510(k) K133475

STRUXXURE ANTERIOR CERVICAL PLATE AND SCREWS by Nexxt Spine, LLC — Product Code KWQ

K133475 is an FDA 510(k) premarket notification submitted by Nexxt Spine, LLC for the device "STRUXXURE ANTERIOR CERVICAL PLATE AND SCREWS". The FDA issued a decision of Substantially Equivalent on December 19, 2013. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Nexxt Spine, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2013
Date Received
November 12, 2013
Clearance Type
Special
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