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510(k) K100765

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

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.

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  • 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)