FDA 510(k)

COFIELD TOTAL SHOULDER SYSTEM

K-Number: K070565 · 2007-05-18

Decision Date2007-05-18

Product CodeMBF

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

COFIELD TOTAL SHOULDER SYSTEM 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 2007-05-18 under 510(k) number K070565. The device is classified under product code MBF. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COFIELD TOTAL SHOULDER SYSTEM?

COFIELD TOTAL SHOULDER SYSTEM is a medical device that received FDA 510(k) clearance on 2007-05-18. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K070565.

When did COFIELD TOTAL SHOULDER SYSTEM receive FDA 510(k) clearance?

COFIELD TOTAL SHOULDER SYSTEM received FDA 510(k) clearance on 2007-05-18, under 510(k) number K070565.

Who is the listed applicant for COFIELD TOTAL SHOULDER SYSTEM?

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 COFIELD TOTAL SHOULDER SYSTEM?

The FDA product code for COFIELD TOTAL SHOULDER SYSTEM is MBF.

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Other records listing Smith & Nephew, Inc. as applicant

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Related Devices (Code: MBF)

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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.