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FDA 510(k)

SMARTSCREW MODEL 222006...227510

K-Number: K003077 · 2001-04-26

ApplicantBionx Implants, Ltd.
Decision Date2001-04-26
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SMARTSCREW MODEL 222006...227510 is the device name listed in this FDA 510(k) record. The listed applicant is Bionx Implants, Ltd.. It received FDA 510(k) clearance on 2001-04-26 under 510(k) number K003077. 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 SMARTSCREW MODEL 222006...227510?

SMARTSCREW MODEL 222006...227510 is a medical device that received FDA 510(k) clearance on 2001-04-26. The listed applicant is Bionx Implants, Ltd.. The 510(k) number is K003077.

When did SMARTSCREW MODEL 222006...227510 receive FDA 510(k) clearance?

SMARTSCREW MODEL 222006...227510 received FDA 510(k) clearance on 2001-04-26, under 510(k) number K003077.

Who is the listed applicant for SMARTSCREW MODEL 222006...227510?

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

What is the FDA product code for SMARTSCREW MODEL 222006...227510?

The FDA product code for SMARTSCREW MODEL 222006...227510 is HWC. This falls under the Cardiovascular category.

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Other records listing Bionx Implants, 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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