Cleared Traditional

Interspinous Plate System

K142378 · Precision Spine, Inc. · Orthopedic

Dec 2014

Decision

114d

Days

Class 2

Risk

About This 510(k) Submission

K142378 is an FDA 510(k) clearance for the Interspinous Plate System, a Spinous Process Plate (Class II — Special Controls, product code PEK), submitted by Precision Spine, Inc. (Parsippany, US). The FDA issued a Cleared decision on December 18, 2014, 114 days after receiving the submission on August 26, 2014. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3050.

Submission Details

510(k) Number	K142378 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 26, 2014
Decision Date	December 18, 2014
Days to Decision	114 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.