Cleared Special

Precision Spine Interspinous Plate System

K151863 · Precision Spine, Inc. · Orthopedic

Aug 2015

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K151863 is an FDA 510(k) clearance for the Precision Spine 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 August 7, 2015, 30 days after receiving the submission on July 8, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3050.

Submission Details

510(k) Number	K151863 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 08, 2015
Decision Date	August 07, 2015
Days to Decision	30 days
Submission Type	Special
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.