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510(k) K162402

4CIS® Marlin ACIF Cage System by Solco Biomedical Co., Ltd. — Product Code ODP

K162402 is an FDA 510(k) premarket notification submitted by Solco Biomedical Co., Ltd. for the device "4CIS® Marlin ACIF Cage System". The FDA issued a decision of Substantially Equivalent on February 16, 2017. The device falls under product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical), a Class II device regulated under 21 CFR 888.3080. Solco Biomedical Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 2017
Date Received
August 26, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intervertebral Fusion Device With Bone Graft, Cervical
Device Class
Class II
Regulation Number
888.3080
Review Panel
OR
Submission Type

Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.

Other clearances by Solco Biomedical Co., Ltd.

  • K231655 — 4CIS® Chiron Spinal Fixation System (November 26, 2024)
  • 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)
  • 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 ODP

  • K260840 — BluEX Cervical Expandable Cage System (May 16, 2026)
  • K260850 — OSTEOMNI SPINAL CAGES SYSTEM (May 12, 2026)
  • K260549 — ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System (April 24, 2026)
  • K253260 — ORIO-3D Cage System (April 16, 2026)
  • K260340 — HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, (April 13, 2026)
  • K242303 — MOD-C (April 1, 2026)
  • K252240 — Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System (March 30, 2026)
  • K252432 — Flex-Z™ Cervical Cage (March 25, 2026)
  • K254105 — Hive™ Standalone Cervical System and Hive™ C Interbody System (February 13, 2026)
  • K252205 — Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Inte (January 16, 2026)

FDA data resources