FDA 510(k)

SMARTSCREW II, MODELS 232010, 232012, 232014, 232016, 232018, 232020

K-Number: K042295 · 2004-09-16

Decision Date2004-09-16

Product CodeHWC

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

SMARTSCREW II, MODELS 232010, 232012, 232014, 232016, 232018, 232020 is the device name listed in this FDA 510(k) record. The listed applicant is Linvatec Biomaterials, Ltd.. It received FDA 510(k) clearance on 2004-09-16 under 510(k) number K042295. 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 II, MODELS 232010, 232012, 232014, 232016, 232018, 232020?

SMARTSCREW II, MODELS 232010, 232012, 232014, 232016, 232018, 232020 is a medical device that received FDA 510(k) clearance on 2004-09-16. The listed applicant is Linvatec Biomaterials, Ltd.. The 510(k) number is K042295.

When did SMARTSCREW II, MODELS 232010, 232012, 232014, 232016, 232018, 232020 receive FDA 510(k) clearance?

SMARTSCREW II, MODELS 232010, 232012, 232014, 232016, 232018, 232020 received FDA 510(k) clearance on 2004-09-16, under 510(k) number K042295.

Who is the listed applicant for SMARTSCREW II, MODELS 232010, 232012, 232014, 232016, 232018, 232020?

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

What is the FDA product code for SMARTSCREW II, MODELS 232010, 232012, 232014, 232016, 232018, 232020?

The FDA product code for SMARTSCREW II, MODELS 232010, 232012, 232014, 232016, 232018, 232020 is HWC. This falls under the Cardiovascular category.

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Other records listing Linvatec Biomaterials, Ltd. as applicant

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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.