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510(k) K043578

THE 4CIS SPINAL SYSTEM AND 4CIS LOW BACK SYSTEM by Solco Biomedical Co., Ltd. — Product Code MNH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 2005
Date Received
December 28, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthosis, Spondylolisthesis Spinal Fixation
Device Class
Class II
Regulation Number
888.3070
Review Panel
OR
Submission Type

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  • K182489 — 4CIS® Pinehurst Anterior Cervical Plate system (January 16, 2019)
  • 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)

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  • K153404 — Zavation Spinal System (April 21, 2016)
  • K160020 — Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System (March 2, 2016)
  • K143013 — Spinal Inner Fixation System (December 11, 2015)
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