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FDA 510(k)

AMC ANTIMICROBIAL PIN/WIRE SLEEVE

K-Number: K012193 · 2002-07-11

Decision Date2002-07-11
Product CodeJEC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AMC ANTIMICROBIAL PIN/WIRE 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 2002-07-11 under 510(k) number K012193. 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 AMC ANTIMICROBIAL PIN/WIRE SLEEVE?

AMC ANTIMICROBIAL PIN/WIRE SLEEVE is a medical device that received FDA 510(k) clearance on 2002-07-11. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K012193.

When did AMC ANTIMICROBIAL PIN/WIRE SLEEVE receive FDA 510(k) clearance?

AMC ANTIMICROBIAL PIN/WIRE SLEEVE received FDA 510(k) clearance on 2002-07-11, under 510(k) number K012193.

Who is the listed applicant for AMC ANTIMICROBIAL PIN/WIRE 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 AMC ANTIMICROBIAL PIN/WIRE SLEEVE?

The FDA product code for AMC ANTIMICROBIAL PIN/WIRE SLEEVE is JEC.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Other records listing Smith & Nephew, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 509 devices →

Related Devices (Code: JEC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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