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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 the device name listed in this FDA 510(k) record. The listed applicant is FH Industrie. It received FDA 510(k) clearance on 2023-08-29 under 510(k) 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. The listed applicant is FH Industrie. The 510(k) number is K232226.

When did ARROW Off-Centred Humeral Insert receive FDA 510(k) clearance?

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

Who is the listed applicant for ARROW Off-Centred Humeral Insert?

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 ARROW Off-Centred Humeral Insert?

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

Other records listing FH Industrie 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.

K254003JARVIS Metaphyseal StemK253345JARVIS Diaphyseal Stem StandardK252411JARVIS Glenoid Reverse Shoulder ProsthesisK242253JARVIS Glenoid Reverse Shoulder ProsthesisK220758e-Ortho Shoulder Software v1.1K202024ARROW Short Stem Humeral System

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Related Devices (Code: PHX)

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.

K260556Veritas Shoulder SystemRestor3DK261683Augment Off-Axis Instrument SystemZimmer, Inc.K260102Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder SystemStryker Corporation (Tornier, Inc.)K261016MSS - Humeral reverse liners extensionMedacta International, SAK253992Veritas Reverse Total Shoulder SystemRestor3DK252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics

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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