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510(k) K100765

FIXPINE II SYSTEM by Dio Medical Co., Ltd. — Product Code MNI

K100765 is an FDA 510(k) premarket notification submitted by Dio Medical Co., Ltd. for the device "FIXPINE II SYSTEM". The FDA issued a decision of Substantially Equivalent on July 19, 2010. The device falls under product code MNI (Orthosis, Spinal Pedicle 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 19, 2010
Date Received
March 17, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthosis, Spinal Pedicle 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)
  • K111362 — REXIOUS SPINAL FIXATION SYSTEM (July 21, 2011)

Other clearances for product code MNI

  • K171497 — Mikron Spinal Fixation System (October 12, 2017)
  • K160731 — LumFix Spinal Fixation Sytem (October 4, 2016)
  • K151458 — Double Medical Universal Spine System (August 22, 2016)
  • K153273 — MySpine Pedicle Screw Placement Guides - LP (June 29, 2016)
  • K160124 — LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation (April 4, 2016)
  • K160320 — Premier (April 1, 2016)
  • K160003 — Sniper (R) Spine System (February 26, 2016)
  • K152324 — YAHUA Spinal System (February 1, 2016)
  • K143222 — FIREFLY Pedicle Screw Navigation Guide (December 11, 2015)
  • K150684 — WASTON General Spinal System (November 18, 2015)

FDA data resources