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510(k) K241738

PYXIS 3D Titanium Cervical Cage system by GS Medical Co., Ltd. — Product Code ODP

K241738 is an FDA 510(k) premarket notification submitted by GS Medical Co., Ltd. for the device "PYXIS 3D Titanium Cervical Cage system". The FDA issued a decision of Substantially Equivalent on August 20, 2024. The device falls under product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical), a Class II device regulated under 21 CFR 888.3080. GS Medical Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 2024
Date Received
June 17, 2024
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 GS Medical Co., Ltd.

  • K243073 — AnyPlus Navigated Instruments System (December 6, 2024)
  • K240350 — AnyPlus II Spinal Fixation System (April 3, 2024)
  • K231808 — QUASAR Standalone ACIF System (July 20, 2023)
  • K223868 — PYXIS 3D Titanium Cage System (April 26, 2023)
  • K222041 — CYGNUS-C Standalone ACIF System (February 9, 2023)
  • K221687 — Pegasus-X Expandable PLIF System (July 27, 2022)
  • K211797 — TRACKER Plus Kyphoplasty System (October 28, 2021)
  • K200592 — GS Medical AnyPlus PEEK Cage System (August 10, 2020)
  • K192335 — TRACKER Kyphoplasty System (December 4, 2019)
  • K190170 — MVP Cervical Plate System (May 13, 2019)

Other clearances for product code ODP

  • K262061 — Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Po (July 17, 2026)
  • K254130 — C.A. Medical Interbody Fusion System (July 8, 2026)
  • 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)

FDA data resources