FDA 510(k)

ORTHOGUARD AB ANTIMICROBIAL SLEEVE

K-Number: K022676 · 2002-09-23

Decision Date2002-09-23

Product CodeJEC

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

ORTHOGUARD AB ANTIMICROBIAL SLEEVE 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 2002-09-23 under 510(k) number K022676. The device is classified under product code JEC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHOGUARD AB ANTIMICROBIAL SLEEVE?

ORTHOGUARD AB ANTIMICROBIAL SLEEVE is a medical device that received FDA 510(k) clearance on 2002-09-23. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K022676.

When did ORTHOGUARD AB ANTIMICROBIAL SLEEVE receive FDA 510(k) clearance?

ORTHOGUARD AB ANTIMICROBIAL SLEEVE received FDA 510(k) clearance on 2002-09-23, under 510(k) number K022676.

Who is the listed applicant for ORTHOGUARD AB ANTIMICROBIAL SLEEVE?

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 ORTHOGUARD AB ANTIMICROBIAL SLEEVE?

The FDA product code for ORTHOGUARD AB ANTIMICROBIAL SLEEVE is JEC.

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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.