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FDA 510(k)

HOFFMANN II DYNAMIZATION/DISTRACTION ROD-TO-ROD COUPLING

K-Number: K003211 · 2000-12-15

ApplicantHowmedica Osteonics Corp.
Decision Date2000-12-15
Product CodeLXT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HOFFMANN II DYNAMIZATION/DISTRACTION ROD-TO-ROD 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 2000-12-15 under 510(k) number K003211. 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 DYNAMIZATION/DISTRACTION ROD-TO-ROD COUPLING?

HOFFMANN II DYNAMIZATION/DISTRACTION ROD-TO-ROD COUPLING is a medical device that received FDA 510(k) clearance on 2000-12-15. The listed applicant is Howmedica Osteonics Corp.. The 510(k) number is K003211.

When did HOFFMANN II DYNAMIZATION/DISTRACTION ROD-TO-ROD COUPLING receive FDA 510(k) clearance?

HOFFMANN II DYNAMIZATION/DISTRACTION ROD-TO-ROD COUPLING received FDA 510(k) clearance on 2000-12-15, under 510(k) number K003211.

Who is the listed applicant for HOFFMANN II DYNAMIZATION/DISTRACTION ROD-TO-ROD 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 DYNAMIZATION/DISTRACTION ROD-TO-ROD COUPLING?

The FDA product code for HOFFMANN II DYNAMIZATION/DISTRACTION ROD-TO-ROD COUPLING is LXT.

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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.

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