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FDA 510(k)

LITTLE GRAFTER SCREW

K-Number: K040265 · 2004-05-28

ApplicantBiocomposites, Ltd.
Decision Date2004-05-28
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LITTLE GRAFTER SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Biocomposites, Ltd.. It received FDA 510(k) clearance on 2004-05-28 under 510(k) number K040265. 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 LITTLE GRAFTER SCREW?

LITTLE GRAFTER SCREW is a medical device that received FDA 510(k) clearance on 2004-05-28. The listed applicant is Biocomposites, Ltd.. The 510(k) number is K040265.

When did LITTLE GRAFTER SCREW receive FDA 510(k) clearance?

LITTLE GRAFTER SCREW received FDA 510(k) clearance on 2004-05-28, under 510(k) number K040265.

Who is the listed applicant for LITTLE GRAFTER SCREW?

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

What is the FDA product code for LITTLE GRAFTER SCREW?

The FDA product code for LITTLE GRAFTER SCREW 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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