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510(k) K113324

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

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

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  • K111362 — REXIOUS SPINAL FIXATION SYSTEM (July 21, 2011)
  • K100765 — FIXPINE II SYSTEM (July 19, 2010)

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  • K142867 — Reliance Posterior Cervical-Thoracic System (April 29, 2015)
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  • 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)
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