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FDA 510(k)

HOFFMANN II ROD TO WIRE COUPLING

K-Number: K053349 · 2005-12-09

ApplicantHowmedica Osteonics Corp.
Decision Date2005-12-09
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HOFFMANN II ROD TO WIRE COUPLING 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 2005-12-09 under 510(k) number K053349. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HOFFMANN II ROD TO WIRE COUPLING?

HOFFMANN II ROD TO WIRE COUPLING is a medical device that received FDA 510(k) clearance on 2005-12-09. The listed applicant is Howmedica Osteonics Corp.. The 510(k) number is K053349.

When did HOFFMANN II ROD TO WIRE COUPLING receive FDA 510(k) clearance?

HOFFMANN II ROD TO WIRE COUPLING received FDA 510(k) clearance on 2005-12-09, under 510(k) number K053349.

Who is the listed applicant for HOFFMANN II ROD TO WIRE COUPLING?

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 ROD TO WIRE COUPLING?

The FDA product code for HOFFMANN II ROD TO WIRE COUPLING is KTT.

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Related Devices (Code: KTT)

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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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