PYXIS 3D Titanium Cage System— 510(k) K223868

Clearance details

Applicant

GS Medical Co., Ltd.

Product code

Code MAX

Device class

Class 2

Regulation

21 CFR 888.3080

Advisory panel

Orthopedic

Date received

2022-12-23

Decision date

2023-04-26

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Cheongju-Si, KR

• K261049 — SCALA® TL2026-08-20
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• K261020 — Symmetrix L Spinal System2026-07-14
• K253420 — Admiral ACP System +18 more2026-07-01

• K243073 — AnyPlus Navigated Instruments System2024-12-06
• K241738 — PYXIS 3D Titanium Cervical Cage system2024-08-20
• K240350 — AnyPlus II Spinal Fixation System2024-04-03
• K231808 — QUASAR Standalone ACIF System2023-07-20
• K222041 — CYGNUS-C Standalone ACIF System2023-02-09

Death

13

Injury

1,305

Malfunction

2,885

Total

4,203

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →