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FDA 510(k)

HOFFMANN II MRI EXTERNAL FIXATION SYSTEM

K-Number: K051306 · 2005-06-17

ApplicantHowmedica Osteonics Corp.
Decision Date2005-06-17
Product CodeLXT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HOFFMANN II MRI EXTERNAL FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Osteonics Corp.. It received FDA 510(k) clearance on 2005-06-17 under 510(k) number K051306. The device is classified under product code LXT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HOFFMANN II MRI EXTERNAL FIXATION SYSTEM?

HOFFMANN II MRI EXTERNAL FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2005-06-17. The listed applicant is Howmedica Osteonics Corp.. The 510(k) number is K051306.

When did HOFFMANN II MRI EXTERNAL FIXATION SYSTEM receive FDA 510(k) clearance?

HOFFMANN II MRI EXTERNAL FIXATION SYSTEM received FDA 510(k) clearance on 2005-06-17, under 510(k) number K051306.

Who is the listed applicant for HOFFMANN II MRI EXTERNAL FIXATION SYSTEM?

The FDA 510(k) record lists Howmedica Osteonics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HOFFMANN II MRI EXTERNAL FIXATION SYSTEM?

The FDA product code for HOFFMANN II MRI EXTERNAL FIXATION SYSTEM is LXT.

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Related Devices (Code: LXT)

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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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