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FDA 510(k)

OSS/(SCARF)- AND OSW-SCREW

K-Number: K042079 · 2004-12-20

ApplicantO.M.T. Oberflachen-Und Materialtechnologie GmbH
Decision Date2004-12-20
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OSS/(SCARF)- AND OSW-SCREW is the device name listed in this FDA 510(k) record. The listed applicant is O.M.T. Oberflachen-Und Materialtechnologie GmbH. It received FDA 510(k) clearance on 2004-12-20 under 510(k) number K042079. 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 OSS/(SCARF)- AND OSW-SCREW?

OSS/(SCARF)- AND OSW-SCREW is a medical device that received FDA 510(k) clearance on 2004-12-20. The listed applicant is O.M.T. Oberflachen-Und Materialtechnologie GmbH. The 510(k) number is K042079.

When did OSS/(SCARF)- AND OSW-SCREW receive FDA 510(k) clearance?

OSS/(SCARF)- AND OSW-SCREW received FDA 510(k) clearance on 2004-12-20, under 510(k) number K042079.

Who is the listed applicant for OSS/(SCARF)- AND OSW-SCREW?

The FDA 510(k) record lists O.M.T. Oberflachen-Und Materialtechnologie GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OSS/(SCARF)- AND OSW-SCREW?

The FDA product code for OSS/(SCARF)- AND OSW-SCREW is HWC. This falls under the Cardiovascular category.

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Related Devices (Code: HWC)

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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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