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510(k) K231655

4CIS® Chiron Spinal Fixation System by Solco Biomedical Co., Ltd. — Product Code NKB

K231655 is an FDA 510(k) premarket notification submitted by Solco Biomedical Co., Ltd. for the device "4CIS® Chiron Spinal Fixation System". The FDA issued a decision of Substantially Equivalent on November 26, 2024. The device falls under product code NKB (Thoracolumbosacral Pedicle Screw System), a Class II device regulated under 21 CFR 888.3070. Solco Biomedical Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 26, 2024
Date Received
June 6, 2023
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Thoracolumbosacral Pedicle Screw System
Device Class
Class II
Regulation Number
888.3070
Review Panel
OR
Submission Type

Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.

Other clearances by Solco Biomedical Co., Ltd.

  • K203233 — 4CIS Chiron Spinal Fixation System (June 1, 2022)
  • K192044 — 4CIS Marlin PEEK ACIF Cage (December 19, 2019)
  • 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)
  • 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)

Other clearances for product code NKB

  • K253045 — “Socko” Vimax Spinal Fixation System (June 17, 2026)
  • K251251 — ChanPin Pedicle Screw Spinal System (June 9, 2026)
  • K260989 — Varion Thoracolumbar Fixation System (May 15, 2026)
  • K253739 — SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® (May 7, 2026)
  • K261130 — AccelFix Spinal Fixation System (May 5, 2026)
  • K253966 — PERLA® TL Posterior Thoraco-lumbar Fixation System (May 1, 2026)
  • K252542 — LEO Spinal System (April 29, 2026)
  • K253940 — M.U.S.T. Pedicle Screw System - Extension (April 28, 2026)
  • K260216 — CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal System (April 21, 2026)
  • K254274 — ARx® SAI Implant System (April 16, 2026)

FDA data resources