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FDA 510(k)

ARTHREX TRIMIT SCREW, MODEL AR-4161B

K-Number: K031945 · 2003-09-22

ApplicantArthrex, Inc.
Decision Date2003-09-22
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ARTHREX TRIMIT SCREW, MODEL AR-4161B is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2003-09-22 under 510(k) number K031945. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARTHREX TRIMIT SCREW, MODEL AR-4161B?

ARTHREX TRIMIT SCREW, MODEL AR-4161B is a medical device that received FDA 510(k) clearance on 2003-09-22. The listed applicant is Arthrex, Inc.. The 510(k) number is K031945.

When did ARTHREX TRIMIT SCREW, MODEL AR-4161B receive FDA 510(k) clearance?

ARTHREX TRIMIT SCREW, MODEL AR-4161B received FDA 510(k) clearance on 2003-09-22, under 510(k) number K031945.

Who is the listed applicant for ARTHREX TRIMIT SCREW, MODEL AR-4161B?

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

What is the FDA product code for ARTHREX TRIMIT SCREW, MODEL AR-4161B?

The FDA product code for ARTHREX TRIMIT SCREW, MODEL AR-4161B is HWC. This falls under the Cardiovascular category.

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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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