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FDA 510(k)

ARTHREX TENODESIS SCREW FAMILY

K-Number: K041356 · 2004-11-04

ApplicantArthrex, Inc.
Decision Date2004-11-04
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ARTHREX TENODESIS SCREW FAMILY is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2004-11-04 under 510(k) number K041356. 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 TENODESIS SCREW FAMILY?

ARTHREX TENODESIS SCREW FAMILY is a medical device that received FDA 510(k) clearance on 2004-11-04. The listed applicant is Arthrex, Inc.. The 510(k) number is K041356.

When did ARTHREX TENODESIS SCREW FAMILY receive FDA 510(k) clearance?

ARTHREX TENODESIS SCREW FAMILY received FDA 510(k) clearance on 2004-11-04, under 510(k) number K041356.

Who is the listed applicant for ARTHREX TENODESIS SCREW FAMILY?

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 TENODESIS SCREW FAMILY?

The FDA product code for ARTHREX TENODESIS SCREW FAMILY is HWC. This falls under the Cardiovascular category.

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Other records listing Arthrex, Inc. as applicant

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Related Devices (Code: HWC)

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.

K262975Arthrex Beaming SystemArthrex, Inc.K260995DynaNail Helix® Fixation SystemMedShape, Inc.K254280F.A.S.T ScrewSteps OrthoK261057ActivaScrew™ Cannulated COMBioretec, Ltd.K260106OsteoCoil™ GT Active Compression SystemFlower Orthopedics Corporation DBA Conventus Flower OrthopedK262344Large Compression ScrewsTriMed, Inc.

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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