Cleared Traditional

Spinal Elements' Spinous Process Plate System

K160465 · Spinal Elements, Inc. · Orthopedic

Jul 2016

Decision

160d

Days

Class 2

Risk

About This 510(k) Submission

K160465 is an FDA 510(k) clearance for the Spinal Elements' Spinous Process Plate System, a Spinous Process Plate (Class II — Special Controls, product code PEK), submitted by Spinal Elements, Inc. (Carlsbad, US). The FDA issued a Cleared decision on July 28, 2016, 160 days after receiving the submission on February 19, 2016. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3050.

Submission Details

510(k) Number	K160465 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 19, 2016
Decision Date	July 28, 2016
Days to Decision	160 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	PEK — Spinous Process Plate
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3050
Definition	A Posterior, Non-pedicle Supplemental Fixation Device Intended For Single Level Use In The Non-cervical Spine (t1-s1). It Is Intended For Single Level Plate Fixation/attachment To Spinous Process For The Purpose Of Achieving Supplemental Fusion In The Following Conditions: Degenerative Disc Disease (defined As Back Pain Of Discogenic Origin With Degeneration Of The Disc Confirmed By History And Radiographic Studies), Trauma (i.e., Fracture Or Dislocation), Spondylolisthesis, And/or Tumor. It Is Not Intended For Stand-alone Use.