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FDA 510(k)

EBA One Nailing System

K-Number: K183666 · 2019-11-14

ApplicantCitieffe S.R.L.
Decision Date2019-11-14
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EBA One Nailing System 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 2019-11-14 under 510(k) number K183666. 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 EBA One Nailing System?

EBA One Nailing System is a medical device that received FDA 510(k) clearance on 2019-11-14. The listed applicant is Citieffe S.R.L.. The 510(k) number is K183666.

When did EBA One Nailing System receive FDA 510(k) clearance?

EBA One Nailing System received FDA 510(k) clearance on 2019-11-14, under 510(k) number K183666.

Who is the listed applicant for EBA One Nailing System?

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 EBA One Nailing System?

The FDA product code for EBA One Nailing System 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.

K250197Estremo Fibular NailK181540Estremo 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

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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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