Huvex Interspinous Fixation System— 510(k) K162849

Name: FDA 510(k) clearance K162849
Creator: U.S. Food and Drug Administration
Published: 2017-02-16

Substantially Equivalent

Dio Medical Co., Ltd.

FDA 510(k) clearance K162849 for Huvex Interspinous Fixation System, Substantially Equivalent on 2017-02-16. Applicant: Dio Medical Co., Ltd.. Device class: 2.

Clearance details

Applicant: Dio Medical Co., Ltd.
Product code: Code PEK
Device class: Class 2
Regulation: 21 CFR 888.3050
Advisory panel: Orthopedic
Date received: 2016-10-11
Decision date: 2017-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jungwon-Gu Sungnam-Si, KR

Download summary PDF View on FDA.gov ↗

Recent devices under product code PEK

view all

K253250 — Minuteman® G6 MIS Fusion Plate2025-12-01
K234051 — Minuteman G5 MIS Fusion Plate +3 more2024-01-18
K233527 — Minuteman G5 MIS Fusion Plate +3 more2023-11-29
K232484 — KeyLift Expandable Interlaminar Stabilization System2023-10-19
K231807 — primaLOK SP Interspinous Fusion System2023-08-15

More clearances from Dio Medical Co., Ltd.

view all

K162220 — DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) Cage2016-11-21
K122872 — INTERVERTEBRAL BODY FUSION DEVICE2013-02-28
K121862 — REX ANTERIOR CERVICAL PLATE SYSTEM2012-10-31
K113324 — REXIOUS HOOK FIXATION SYSTEMS2012-03-28
K111362 — REXIOUS SPINAL FIXATION SYSTEM2011-07-21

Data sourced from openFDA. This site is unofficial and independent of the FDA.