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FDA 510(k)

TELEGRAPH® EVOLUTION Humeral Nailing System

K-Number: K200127 · 2020-10-01

ApplicantFH Industrie
Decision Date2020-10-01
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TELEGRAPH® EVOLUTION Humeral Nailing System is the device name listed in this FDA 510(k) record. The listed applicant is FH Industrie. It received FDA 510(k) clearance on 2020-10-01 under 510(k) number K200127. 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 TELEGRAPH® EVOLUTION Humeral Nailing System?

TELEGRAPH® EVOLUTION Humeral Nailing System is a medical device that received FDA 510(k) clearance on 2020-10-01. The listed applicant is FH Industrie. The 510(k) number is K200127.

When did TELEGRAPH® EVOLUTION Humeral Nailing System receive FDA 510(k) clearance?

TELEGRAPH® EVOLUTION Humeral Nailing System received FDA 510(k) clearance on 2020-10-01, under 510(k) number K200127.

Who is the listed applicant for TELEGRAPH® EVOLUTION Humeral Nailing System?

The FDA 510(k) record lists FH Industrie as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TELEGRAPH® EVOLUTION Humeral Nailing System?

The FDA product code for TELEGRAPH® EVOLUTION Humeral Nailing System is HSB.

Other records listing FH Industrie as applicant

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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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