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FDA 510(k)

ARROW Off-Centred Humeral Insert

K-Number: K232226 · 2023-08-29

ApplicantFH Industrie
Decision Date2023-08-29
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ARROW Off-Centred Humeral Insert is a medical device manufactured by FH Industrie. It received FDA 510(k) clearance on 2023-08-29 under approval number K232226. The device is classified under product code PHX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARROW Off-Centred Humeral Insert?

ARROW Off-Centred Humeral Insert is a medical device that received FDA 510(k) clearance on 2023-08-29. It is manufactured by FH Industrie. The 510(k) number is K232226.

When was ARROW Off-Centred Humeral Insert approved by the FDA?

ARROW Off-Centred Humeral Insert received FDA 510(k) clearance on 2023-08-29, under approval number K232226.

What company makes ARROW Off-Centred Humeral Insert?

ARROW Off-Centred Humeral Insert is manufactured by FH Industrie.

What is the FDA product code for ARROW Off-Centred Humeral Insert?

The FDA product code for ARROW Off-Centred Humeral Insert is PHX.

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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.