FDA 510(k)

SMITH & NEPHEW ELECTROTHERMAL 20S SPINE GENERATOR, MODEL 7209975

K-Number: K033981 · 2004-02-25

Decision Date2004-02-25

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

SMITH & NEPHEW ELECTROTHERMAL 20S SPINE GENERATOR, MODEL 7209975 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 2004-02-25 under 510(k) number K033981. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMITH & NEPHEW ELECTROTHERMAL 20S SPINE GENERATOR, MODEL 7209975?

SMITH & NEPHEW ELECTROTHERMAL 20S SPINE GENERATOR, MODEL 7209975 is a medical device that received FDA 510(k) clearance on 2004-02-25. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K033981.

When did SMITH & NEPHEW ELECTROTHERMAL 20S SPINE GENERATOR, MODEL 7209975 receive FDA 510(k) clearance?

SMITH & NEPHEW ELECTROTHERMAL 20S SPINE GENERATOR, MODEL 7209975 received FDA 510(k) clearance on 2004-02-25, under 510(k) number K033981.

Who is the listed applicant for SMITH & NEPHEW ELECTROTHERMAL 20S SPINE GENERATOR, MODEL 7209975?

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 ELECTROTHERMAL 20S SPINE GENERATOR, MODEL 7209975?

The FDA product code for SMITH & NEPHEW ELECTROTHERMAL 20S SPINE GENERATOR, MODEL 7209975 is GEI.

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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.