Gemini Medical Cage System— 510(k) K242267

Clearance details

Applicant

ZheJiang Decans Medical Devices Co., Ltd.

Product code

Code MAX

Device class

Class 2

Regulation

21 CFR 888.3080

Advisory panel

Orthopedic

Date received

2024-08-01

Decision date

2024-10-08

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Jiaxing, CN

• K261049 — SCALA® TL2026-08-20
• K261430 — TruLift Expandable System2026-07-28
• K253011 — Catalyft PL Expandable Interbody System2026-07-17
• K261020 — Symmetrix L Spinal System2026-07-14
• K253420 — Admiral ACP System +18 more2026-07-01

• K253046 — HERA Interlocking Intramedullary Nailing System2026-06-16
• K253195 — TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems2026-06-02
• K252930 — AQUA Laminoplasty Systems2026-05-27
• K253130 — Dione PEEK Screw System2026-05-27
• K252776 — ARIES Anterior Cervical Plate Systems2026-05-14

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 →