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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 a medical device manufactured by FH Industrie. It received FDA 510(k) clearance on 2020-10-01 under approval 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. It is manufactured by FH Industrie. The 510(k) number is K200127.

When was TELEGRAPH® EVOLUTION Humeral Nailing System approved by the FDA?

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

What company makes TELEGRAPH® EVOLUTION Humeral Nailing System?

TELEGRAPH® EVOLUTION Humeral Nailing System is manufactured by FH Industrie.

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

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

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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.