FDA 510(k)

RCI FIXATION SCREWS

K-Number: K980841 · 1998-05-20

Decision Date1998-05-20

Product CodeHWC

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

RCI FIXATION SCREWS is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 1998-05-20 under 510(k) number K980841. 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 RCI FIXATION SCREWS?

RCI FIXATION SCREWS is a medical device that received FDA 510(k) clearance on 1998-05-20. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K980841.

When did RCI FIXATION SCREWS receive FDA 510(k) clearance?

RCI FIXATION SCREWS received FDA 510(k) clearance on 1998-05-20, under 510(k) number K980841.

Who is the listed applicant for RCI FIXATION SCREWS?

The FDA 510(k) record lists Smith & Nephew, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RCI FIXATION SCREWS?

The FDA product code for RCI FIXATION SCREWS 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.