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FDA 510(k)

BOSWORTH CORACO-CLAVICULAR SCREW

K-Number: K023294 · 2002-10-09

ApplicantHowmedica Osteonics Corp.
Decision Date2002-10-09
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BOSWORTH CORACO-CLAVICULAR SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Osteonics Corp.. It received FDA 510(k) clearance on 2002-10-09 under 510(k) number K023294. 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 BOSWORTH CORACO-CLAVICULAR SCREW?

BOSWORTH CORACO-CLAVICULAR SCREW is a medical device that received FDA 510(k) clearance on 2002-10-09. The listed applicant is Howmedica Osteonics Corp.. The 510(k) number is K023294.

When did BOSWORTH CORACO-CLAVICULAR SCREW receive FDA 510(k) clearance?

BOSWORTH CORACO-CLAVICULAR SCREW received FDA 510(k) clearance on 2002-10-09, under 510(k) number K023294.

Who is the listed applicant for BOSWORTH CORACO-CLAVICULAR SCREW?

The FDA 510(k) record lists Howmedica Osteonics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BOSWORTH CORACO-CLAVICULAR SCREW?

The FDA product code for BOSWORTH CORACO-CLAVICULAR SCREW is HWC. This falls under the Cardiovascular category.

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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.

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