Cleared Traditional

HA Minuteman G3 MIS Fusion Plate

K151741 · Spinal Simplicity, LLC · Orthopedic

Aug 2015

Decision

55d

Days

Class 2

Risk

About This 510(k) Submission

K151741 is an FDA 510(k) clearance for the HA Minuteman G3 MIS Fusion Plate, a Spinous Process Plate (Class II — Special Controls, product code PEK), submitted by Spinal Simplicity, LLC (Overland Park, US). The FDA issued a Cleared decision on August 20, 2015, 55 days after receiving the submission on June 26, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3050.

Submission Details

510(k) Number	K151741 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 26, 2015
Decision Date	August 20, 2015
Days to Decision	55 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.