Cleared Traditional

primaLOK? SP Interspinous Fusion System

K231807 · Wenzel Spine, Inc. · Orthopedic

Aug 2023

Decision

56d

Days

Class 2

Risk

About This 510(k) Submission

K231807 is an FDA 510(k) clearance for the primaLOK? SP Interspinous Fusion System, a Spinous Process Plate (Class II — Special Controls, product code PEK), submitted by Wenzel Spine, Inc. (Austin, US). The FDA issued a Cleared decision on August 15, 2023, 56 days after receiving the submission on June 20, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3050.

Submission Details

510(k) Number	K231807 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 20, 2023
Decision Date	August 15, 2023
Days to Decision	56 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.