3d Cage Cervical— 510(k) K253041

Name: FDA 510(k) clearance K253041
Creator: U.S. Food and Drug Administration
Published: 2026-07-23

Substantially Equivalent

Fims Co., Ltd.

FDA 510(k) clearance K253041 for 3d Cage Cervical, Substantially Equivalent on 2026-07-23. Applicant: Fims Co., Ltd.. Device class: 2.

Summary

Fims's 3d Cage Cervical is filed under ODP, cervical intervertebral fusion devices with bone graft. The record doesn't give sizes or materials.

Class II, 21 CFR 888.3080. Orthopedic is both the classification panel and the review panel, and it was a Traditional 510(k).

Fims filed from Suwon-si, South Korea. Review took 304 calendar days (September 22, 2025 to July 23, 2026).

Clearance details

Applicant: Fims Co., Ltd.
Product code: Product code ODP
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2025-09-22
Decision date: 2026-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suwon-Si, KR

Download summary PDF View on FDA.gov ↗

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K262595 — VariLift-C Cervical Interbody Fusion System2026-08-26
K262489 — BluEX Cervical Expandable Cage System2026-08-18
K262061 — Tritanium® C Anterior Cervical Cage +16 more2026-07-17
K254130 — C.A. Medical Interbody Fusion System2026-07-08
K260840 — BluEX Cervical Expandable Cage System2026-05-16

More clearances from Fims Co., Ltd.

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K180347 — 3d Cage2019-10-28

Adverse events under product code ODP

product code ODP

Injury: 310
Total: 310

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.