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FDA 510(k)

MODIFICATION TO BILOK ST SCREW

K-Number: K071115 · 2007-05-17

ApplicantBiocomposites, Ltd.
Decision Date2007-05-17
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO 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 2007-05-17 under 510(k) number K071115. 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 MODIFICATION TO BILOK ST SCREW?

MODIFICATION TO BILOK ST SCREW is a medical device that received FDA 510(k) clearance on 2007-05-17. The listed applicant is Biocomposites, Ltd.. The 510(k) number is K071115.

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

MODIFICATION TO BILOK ST SCREW received FDA 510(k) clearance on 2007-05-17, under 510(k) number K071115.

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

The FDA product code for MODIFICATION TO BILOK ST 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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