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FDA 510(k)

BILOK ST SCREW

K-Number: K033792 · 2004-03-01

ApplicantBiocomposites, Ltd.
Decision Date2004-03-01
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BILOK ST 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 2004-03-01 under 510(k) number K033792. 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 BILOK ST SCREW?

BILOK ST SCREW is a medical device that received FDA 510(k) clearance on 2004-03-01. The listed applicant is Biocomposites, Ltd.. The 510(k) number is K033792.

When did BILOK ST SCREW receive FDA 510(k) clearance?

BILOK ST SCREW received FDA 510(k) clearance on 2004-03-01, under 510(k) number K033792.

Who is the listed applicant for BILOK ST 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 BILOK ST SCREW?

The FDA product code for BILOK ST SCREW is HWC. This falls under the Cardiovascular category.

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Other records listing Biocomposites, Ltd. as applicant

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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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