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510(k) K102458

4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM by Solco Biomedical Co., Ltd. — Product Code MNH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 2011
Date Received
August 27, 2010
Clearance Type
Special
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

Other clearances by Solco Biomedical Co., Ltd.

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  • K190563 — 4CIS PEEK PLIF Cage, 4CIS Pebble Beach PEEK PLIF Cage, 4CIS Torrey Pines PEEK TL (September 18, 2019)
  • K190471 — 4CIS® Chiron Spinal Fixation System (July 24, 2019)
  • 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)
  • K101818 — 4CIS VANE SPINE SYSTEM (February 11, 2011)
  • K092162 — 4CIS PEEK, PLIF AND TLIF CAGE SYSTEM (January 6, 2010)

Other clearances for product code MNH

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  • K161151 — Spinal fixation system (September 21, 2016)
  • K162189 — ANAX™ 5.5 Spinal System (August 30, 2016)
  • K151362 — HC Spinal System (May 5, 2016)
  • 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)
  • K151695 — Romeo posterior osteosynthesis system (September 10, 2015)