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510(k) K113324

REXIOUS HOOK FIXATION SYSTEMS by Dio Medical Co., Ltd. — Product Code KWP

K113324 is an FDA 510(k) premarket notification submitted by Dio Medical Co., Ltd. for the device "REXIOUS HOOK FIXATION SYSTEMS". The FDA issued a decision of Substantially Equivalent on March 28, 2012. The device falls under product code KWP (Appliance, Fixation, Spinal Interlaminal), a Class II device regulated under 21 CFR 888.3050. Dio Medical Co., Ltd. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 2012
Date Received
November 10, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Spinal Interlaminal
Device Class
Class II
Regulation Number
888.3050
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)
  • K111362 — REXIOUS SPINAL FIXATION SYSTEM (July 21, 2011)
  • K100765 — FIXPINE II SYSTEM (July 19, 2010)

Other clearances for product code KWP

  • K143278 — LnK Posterior Cervical Fixation System (July 29, 2015)
  • K150753 — OASYS System (June 9, 2015)
  • K150851 — Sure Lok Mini Posterior Cervical/Upper Thoracic System (June 4, 2015)
  • K142867 — Reliance Posterior Cervical-Thoracic System (April 29, 2015)
  • K150254 — Streamline OCT Occipito-Cervico-Thoracic System (April 28, 2015)
  • K142253 — SOLSTICE OCT System (April 23, 2015)
  • K150229 — SOLSTICE OCT System (April 7, 2015)
  • K143249 — SOLSTICE OCT System (April 7, 2015)
  • K142741 — OASYS System (January 15, 2015)
  • K142558 — Caspian OCT/MESA Mini/DENALI Mini Spinal System (December 22, 2014)

FDA data resources