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510(k) K121862

REX ANTERIOR CERVICAL PLATE SYSTEM by Dio Medical Co., Ltd. — Product Code KWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 2012
Date Received
June 26, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Spinal Intervertebral Body
Device Class
Class II
Regulation Number
888.3060
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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