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FDA 510(k)

ARTHREX CANCELLOUS SCREW AND WASHER

K-Number: K945426 · 1995-04-14

ApplicantArthrex, Inc.
Decision Date1995-04-14
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

ARTHREX CANCELLOUS SCREW AND WASHER is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 1995-04-14 under 510(k) number K945426. 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 for Some Indications.

Frequently Asked Questions

What is the ARTHREX CANCELLOUS SCREW AND WASHER?

ARTHREX CANCELLOUS SCREW AND WASHER is a medical device that received FDA 510(k) clearance on 1995-04-14. The listed applicant is Arthrex, Inc.. The 510(k) number is K945426.

When did ARTHREX CANCELLOUS SCREW AND WASHER receive FDA 510(k) clearance?

ARTHREX CANCELLOUS SCREW AND WASHER received FDA 510(k) clearance on 1995-04-14, under 510(k) number K945426.

Who is the listed applicant for ARTHREX CANCELLOUS SCREW AND WASHER?

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 CANCELLOUS SCREW AND WASHER?

The FDA product code for ARTHREX CANCELLOUS SCREW AND WASHER is HWC. This falls under the Cardiovascular category.

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Other records listing Arthrex, Inc. 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.

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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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