FDA 510(k)

RCI FIXATION SCREWS (WITH ASSORTED SIZES)

K-Number: K992945 · 1999-11-18

Decision Date1999-11-18

Product CodeHWC

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

RCI FIXATION SCREWS (WITH ASSORTED SIZES) 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 1999-11-18 under 510(k) number K992945. 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 (WITH ASSORTED SIZES)?

RCI FIXATION SCREWS (WITH ASSORTED SIZES) is a medical device that received FDA 510(k) clearance on 1999-11-18. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K992945.

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

RCI FIXATION SCREWS (WITH ASSORTED SIZES) received FDA 510(k) clearance on 1999-11-18, under 510(k) number K992945.

Who is the listed applicant for RCI FIXATION SCREWS (WITH ASSORTED SIZES)?

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 (WITH ASSORTED SIZES)?

The FDA product code for RCI FIXATION SCREWS (WITH ASSORTED SIZES) 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.