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FDA 510(k)

Estremo Fibular Nail

K-Number: K250197 · 2025-10-17

ApplicantCitieffe S.R.L.
Decision Date2025-10-17
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Estremo Fibular Nail is the device name listed in this FDA 510(k) record. The listed applicant is Citieffe S.R.L.. It received FDA 510(k) clearance on 2025-10-17 under 510(k) number K250197. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Estremo Fibular Nail?

Estremo Fibular Nail is a medical device that received FDA 510(k) clearance on 2025-10-17. The listed applicant is Citieffe S.R.L.. The 510(k) number is K250197.

When did Estremo Fibular Nail receive FDA 510(k) clearance?

Estremo Fibular Nail received FDA 510(k) clearance on 2025-10-17, under 510(k) number K250197.

Who is the listed applicant for Estremo Fibular Nail?

The FDA 510(k) record lists Citieffe S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Estremo Fibular Nail?

The FDA product code for Estremo Fibular Nail is HSB.

Other records listing Citieffe S.R.L. 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.

K183666EBA One Nailing SystemK181540Estremo Citieffe Nailing SystemK180150PL8 Wrist Reconstruction PlateK163323Dolphix® External Fixation System MR Conditional

Related Devices (Code: HSB)

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.

K261481Pangea Femur Reconstruction SystemStryker GmbHK261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized OrthopedicsK253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)Suzhou and Science & Technology Development Corp.K253155Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd.K253046HERA Interlocking Intramedullary Nailing SystemZheJiang Decans Medical Devices Co., Ltd.K260146FITBONE® TRANSPORT AND LENGTHENING SYSTEMOrthofix Srl

Official Source

View on FDA Database →

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

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