Medical Device Manufacturer · US , Santa Fe Springs , CA

Dio Medical Co., Ltd. - FDA 510(k) Cleared Devices

7 submissions · 7 cleared · Since 2010

Recent clearances: Huvex Interspinous Fixation System, DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) Cage, INTERVERTEBRAL BODY FUSION DEVICE

View 7 510(k) Devices ↓

7

Total

7

Cleared

0

Denied

FDA 510(k) Regulatory Record - Dio Medical Co., Ltd. Orthopedic ✕

7 devices

1-7 of 7

Cleared Feb 16, 2017

Huvex Interspinous Fixation System

Orthopedic · 128d

Cleared Nov 21, 2016

DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) Cage

Orthopedic · 105d

Cleared Feb 28, 2013

INTERVERTEBRAL BODY FUSION DEVICE

Orthopedic · 162d

Cleared Oct 31, 2012

REX ANTERIOR CERVICAL PLATE SYSTEM

Orthopedic · 127d

Cleared Mar 28, 2012

REXIOUS HOOK FIXATION SYSTEMS

Orthopedic · 139d

Cleared Jul 21, 2011

REXIOUS SPINAL FIXATION SYSTEM

Orthopedic · 66d

Cleared Jul 19, 2010

FIXPINE II SYSTEM

Orthopedic · 124d