510(k) K133287

PRESSON SPINAL FIXATION SYSTEM by Nexus Spine, LLC — Product Code MNH

K133287 is an FDA 510(k) premarket notification submitted by Nexus Spine, LLC for the device "PRESSON SPINAL FIXATION SYSTEM". The FDA issued a decision of Substantially Equivalent on February 25, 2014. The device falls under product code MNH (Orthosis, Spondylolisthesis Spinal Fixation), a Class II device regulated under 21 CFR 888.3070. Nexus Spine, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 25, 2014
Date Received
October 25, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthosis, Spondylolisthesis Spinal Fixation
Device Class
Class II
Regulation Number
888.3070
Review Panel
OR
Submission Type