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510(k) K111362

REXIOUS SPINAL FIXATION SYSTEM by Dio Medical Co., Ltd. — Product Code MNH

K111362 is an FDA 510(k) premarket notification submitted by Dio Medical Co., Ltd. for the device "REXIOUS SPINAL FIXATION SYSTEM". The FDA issued a decision of Substantially Equivalent on July 21, 2011. The device falls under product code MNH (Orthosis, Spondylolisthesis Spinal Fixation), a Class II device regulated under 21 CFR 888.3070. Dio Medical Co., Ltd. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 2011
Date Received
May 16, 2011
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthosis, Spondylolisthesis Spinal Fixation
Device Class
Class II
Regulation Number
888.3070
Review Panel
OR
Submission Type

Other clearances by Dio Medical Co., Ltd.

  • K162849 — Huvex Interspinous Fixation System (February 16, 2017)
  • K162220 — DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) Cage (November 21, 2016)
  • K122872 — INTERVERTEBRAL BODY FUSION DEVICE (February 28, 2013)
  • K121862 — REX ANTERIOR CERVICAL PLATE SYSTEM (October 31, 2012)
  • K113324 — REXIOUS HOOK FIXATION SYSTEMS (March 28, 2012)
  • K100765 — FIXPINE II SYSTEM (July 19, 2010)

Other clearances for product code MNH

  • K162066 — Reliance Spinal Screw System (December 2, 2016)
  • K162801 — CastleLoc Spinal Fixation System (November 3, 2016)
  • K162143 — FixxSure® X-Link (September 23, 2016)
  • K161151 — Spinal fixation system (September 21, 2016)
  • K162189 — ANAX™ 5.5 Spinal System (August 30, 2016)
  • K151362 — HC Spinal System (May 5, 2016)
  • K153404 — Zavation Spinal System (April 21, 2016)
  • K160020 — Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System (March 2, 2016)
  • K143013 — Spinal Inner Fixation System (December 11, 2015)
  • K151695 — Romeo posterior osteosynthesis system (September 10, 2015)

FDA data resources