510(k) K122081

NUVASIVE LONG LATERAL SPINAL SYSTEM by Nuvasive, Inc. — Product Code KWQ

K122081 is an FDA 510(k) premarket notification submitted by Nuvasive, Inc. for the device "NUVASIVE LONG LATERAL SPINAL SYSTEM". The FDA issued a decision of Substantially Equivalent on February 1, 2013. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Nuvasive, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 2013
Date Received
July 16, 2012
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