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FDA 510(k)

3d Cage Cervical

K-Number: K253041 · 2026-07-23

ApplicantFims Co., Ltd.
Decision Date2026-07-23
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

3d Cage Cervical is the device name listed in this FDA 510(k) record. The listed applicant is Fims Co., Ltd.. It received FDA 510(k) clearance on 2026-07-23 under 510(k) number K253041. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 3d Cage Cervical?

3d Cage Cervical is a medical device that received FDA 510(k) clearance on 2026-07-23. The listed applicant is Fims Co., Ltd.. The 510(k) number is K253041.

When did 3d Cage Cervical receive FDA 510(k) clearance?

3d Cage Cervical received FDA 510(k) clearance on 2026-07-23, under 510(k) number K253041.

Who is the listed applicant for 3d Cage Cervical?

The FDA 510(k) record lists Fims Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3d Cage Cervical?

The FDA product code for 3d Cage Cervical is ODP.

Other records listing Fims Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K1803473d Cage

Related Devices (Code: ODP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262061Tritanium® 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 REPLACEMStryker SpineK254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLCK260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.K260850OSTEOMNI SPINAL CAGES SYSTEMOsteomni, Inc.K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.K253260ORIO-3D Cage SystemSpineCraft

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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