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FDA 510(k)

SMITH & NEPHEW MDF MODULAR SLEEVE

K-Number: K100481 · 2010-07-15

ApplicantSmith & Nephew, Inc.
Decision Date2010-07-15
Product CodeMEH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SMITH & NEPHEW MDF MODULAR 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 2010-07-15 under 510(k) number K100481. 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 MDF MODULAR SLEEVE?

SMITH & NEPHEW MDF MODULAR SLEEVE is a medical device that received FDA 510(k) clearance on 2010-07-15. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K100481.

When did SMITH & NEPHEW MDF MODULAR SLEEVE receive FDA 510(k) clearance?

SMITH & NEPHEW MDF MODULAR SLEEVE received FDA 510(k) clearance on 2010-07-15, under 510(k) number K100481.

Who is the listed applicant for SMITH & NEPHEW MDF MODULAR 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 SMITH & NEPHEW MDF MODULAR SLEEVE?

The FDA product code for SMITH & NEPHEW MDF MODULAR SLEEVE 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.

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