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FDA 510(k)

BIOSTEON CROSS PIN

K-Number: K021351 · 2002-10-17

ApplicantBiocomposites, Ltd.
Decision Date2002-10-17
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BIOSTEON CROSS PIN is the device name listed in this FDA 510(k) record. The listed applicant is Biocomposites, Ltd.. It received FDA 510(k) clearance on 2002-10-17 under 510(k) number K021351. 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 BIOSTEON CROSS PIN?

BIOSTEON CROSS PIN is a medical device that received FDA 510(k) clearance on 2002-10-17. The listed applicant is Biocomposites, Ltd.. The 510(k) number is K021351.

When did BIOSTEON CROSS PIN receive FDA 510(k) clearance?

BIOSTEON CROSS PIN received FDA 510(k) clearance on 2002-10-17, under 510(k) number K021351.

Who is the listed applicant for BIOSTEON CROSS PIN?

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 BIOSTEON CROSS PIN?

The FDA product code for BIOSTEON CROSS PIN 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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