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510(k) K182489

4CIS® Pinehurst Anterior Cervical Plate system by Solco Biomedical Co., Ltd. — Product Code KWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 16, 2019
Date Received
September 11, 2018
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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  • K162402 — 4CIS® Marlin ACIF Cage System (February 16, 2017)
  • K121615 — 4CIS VANE SPINE SYSTEM (August 15, 2012)
  • K102458 — 4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM (June 13, 2011)
  • K101818 — 4CIS VANE SPINE SYSTEM (February 11, 2011)
  • K092162 — 4CIS PEEK, PLIF AND TLIF CAGE SYSTEM (January 6, 2010)

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