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FDA 510(k)

ROUNDED CANNULATED INSIDE-OUT (RCI) ACL SCREW

K-Number: K945687 · 1995-06-22

ApplicantSmith and Nephew Donjoy, Inc.
Decision Date1995-06-22
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

ROUNDED CANNULATED INSIDE-OUT (RCI) ACL SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Smith and Nephew Donjoy, Inc.. It received FDA 510(k) clearance on 1995-06-22 under 510(k) number K945687. 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 for Some Indications.

Frequently Asked Questions

What is the ROUNDED CANNULATED INSIDE-OUT (RCI) ACL SCREW?

ROUNDED CANNULATED INSIDE-OUT (RCI) ACL SCREW is a medical device that received FDA 510(k) clearance on 1995-06-22. The listed applicant is Smith and Nephew Donjoy, Inc.. The 510(k) number is K945687.

When did ROUNDED CANNULATED INSIDE-OUT (RCI) ACL SCREW receive FDA 510(k) clearance?

ROUNDED CANNULATED INSIDE-OUT (RCI) ACL SCREW received FDA 510(k) clearance on 1995-06-22, under 510(k) number K945687.

Who is the listed applicant for ROUNDED CANNULATED INSIDE-OUT (RCI) ACL SCREW?

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

What is the FDA product code for ROUNDED CANNULATED INSIDE-OUT (RCI) ACL SCREW?

The FDA product code for ROUNDED CANNULATED INSIDE-OUT (RCI) ACL SCREW 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.

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