Cleared Traditional

Huvex Interspinous Fusion System

K223790 · Dio Medical Corp. · Orthopedic

Mar 2023

Decision

80d

Days

Class 2

Risk

About This 510(k) Submission

K223790 is an FDA 510(k) clearance for the Huvex Interspinous Fusion System, a Spinous Process Plate (Class II — Special Controls, product code PEK), submitted by Dio Medical Corp. (East Norriton, US). The FDA issued a Cleared decision on March 9, 2023, 80 days after receiving the submission on December 19, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3050.

Submission Details

510(k) Number	K223790 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 19, 2022
Decision Date	March 09, 2023
Days to Decision	80 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.