FDA 510(k)

MINIMALLY INVASIVE SOLUTIONS OSTEOTOMY GUIDE INSTRUMENT

K-Number: K033652 · 2004-02-04

Decision Date2004-02-04

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

MINIMALLY INVASIVE SOLUTIONS OSTEOTOMY GUIDE INSTRUMENT is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer, Inc.. It received FDA 510(k) clearance on 2004-02-04 under 510(k) number K033652. 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 MINIMALLY INVASIVE SOLUTIONS OSTEOTOMY GUIDE INSTRUMENT?

MINIMALLY INVASIVE SOLUTIONS OSTEOTOMY GUIDE INSTRUMENT is a medical device that received FDA 510(k) clearance on 2004-02-04. The listed applicant is Zimmer, Inc.. The 510(k) number is K033652.

When did MINIMALLY INVASIVE SOLUTIONS OSTEOTOMY GUIDE INSTRUMENT receive FDA 510(k) clearance?

MINIMALLY INVASIVE SOLUTIONS OSTEOTOMY GUIDE INSTRUMENT received FDA 510(k) clearance on 2004-02-04, under 510(k) number K033652.

Who is the listed applicant for MINIMALLY INVASIVE SOLUTIONS OSTEOTOMY GUIDE INSTRUMENT?

The FDA 510(k) record lists Zimmer, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MINIMALLY INVASIVE SOLUTIONS OSTEOTOMY GUIDE INSTRUMENT?

The FDA product code for MINIMALLY INVASIVE SOLUTIONS OSTEOTOMY GUIDE INSTRUMENT 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.