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510(k) K162849

Huvex Interspinous Fixation System by Dio Medical Co., Ltd. — Product Code PEK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 2017
Date Received
October 11, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spinous Process Plate
Device Class
Class II
Regulation Number
888.3050
Review Panel
OR
Submission Type

A posterior, non-pedicle supplemental fixation device intended for single level use in the non-cervical spine (T1-S1). It is intended for single level plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), Trauma (i.e., fracture or dislocation), Spondylolisthesis, and/or Tumor. It is not intended for stand-alone use.

Other clearances by Dio Medical Co., Ltd.

  • 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)
  • K100765 — FIXPINE II SYSTEM (July 19, 2010)

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