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FDA 510(k)

Elos® Intramedullary Nailing System

K-Number: K201147 · 2021-07-19

ApplicantIntrauma S.P.A
Decision Date2021-07-19
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Elos® Intramedullary Nailing System is the device name listed in this FDA 510(k) record. The listed applicant is Intrauma S.P.A. It received FDA 510(k) clearance on 2021-07-19 under 510(k) number K201147. 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 Elos® Intramedullary Nailing System?

Elos® Intramedullary Nailing System is a medical device that received FDA 510(k) clearance on 2021-07-19. The listed applicant is Intrauma S.P.A. The 510(k) number is K201147.

When did Elos® Intramedullary Nailing System receive FDA 510(k) clearance?

Elos® Intramedullary Nailing System received FDA 510(k) clearance on 2021-07-19, under 510(k) number K201147.

Who is the listed applicant for Elos® Intramedullary Nailing System?

The FDA 510(k) record lists Intrauma S.P.A as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Elos® Intramedullary Nailing System?

The FDA product code for Elos® Intramedullary Nailing System is HSB.

Other records listing Intrauma S.P.A 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.

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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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