3d Cage Cervical— 510(k) K253041
Substantially EquivalentFims Co., Ltd.
FDA 510(k) clearance K253041 for 3d Cage Cervical, Substantially Equivalent on 2026-07-23. Applicant: Fims Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Fims Co., Ltd.
- Product code
- Code ODP
- Device class
- Class 2
- Regulation
- 21 CFR 888.3080
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Suwon-Si, KR
Recent devices under product code ODP
view all- K262061 — Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEM
- K254130 — C.A. Medical Interbody Fusion System
- K260840 — BluEX Cervical Expandable Cage System
- K260850 — OSTEOMNI SPINAL CAGES SYSTEM
- K260549 — ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System
More clearances from Fims Co., Ltd.
view allAdverse events under product code ODP
product code ODP- Injury
- 310
- Total
- 310
Source: openFDA MAUDE database, through . 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.