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FDA 510(k)

BIOLOK SCREW, BIOSTEON SCREW

K-Number: K003641 · 2001-02-08

ApplicantBiocomposites, Ltd.
Decision Date2001-02-08
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BIOLOK SCREW, BIOSTEON 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 2001-02-08 under 510(k) number K003641. 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 BIOLOK SCREW, BIOSTEON SCREW?

BIOLOK SCREW, BIOSTEON SCREW is a medical device that received FDA 510(k) clearance on 2001-02-08. The listed applicant is Biocomposites, Ltd.. The 510(k) number is K003641.

When did BIOLOK SCREW, BIOSTEON SCREW receive FDA 510(k) clearance?

BIOLOK SCREW, BIOSTEON SCREW received FDA 510(k) clearance on 2001-02-08, under 510(k) number K003641.

Who is the listed applicant for BIOLOK SCREW, BIOSTEON 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 BIOLOK SCREW, BIOSTEON SCREW?

The FDA product code for BIOLOK SCREW, BIOSTEON 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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