FDA 510(k)

SMITH & NEPHEW RADIOPAQUE TRIAL NECKS

K-Number: K113039 · 2012-10-05

Decision Date2012-10-05

Product CodeMEH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

SMITH & NEPHEW RADIOPAQUE TRIAL NECKS 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 2012-10-05 under 510(k) number K113039. The device is classified under product code MEH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMITH & NEPHEW RADIOPAQUE TRIAL NECKS?

SMITH & NEPHEW RADIOPAQUE TRIAL NECKS is a medical device that received FDA 510(k) clearance on 2012-10-05. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K113039.

When did SMITH & NEPHEW RADIOPAQUE TRIAL NECKS receive FDA 510(k) clearance?

SMITH & NEPHEW RADIOPAQUE TRIAL NECKS received FDA 510(k) clearance on 2012-10-05, under 510(k) number K113039.

Who is the listed applicant for SMITH & NEPHEW RADIOPAQUE TRIAL NECKS?

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 SMITH & NEPHEW RADIOPAQUE TRIAL NECKS?

The FDA product code for SMITH & NEPHEW RADIOPAQUE TRIAL NECKS is MEH.

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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.