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FDA 510(k)

DYNAMIC JOINT DISTRACTOR II EXTERNAL FIXATION SYSTEM

K-Number: K002923 · 2000-12-18

ApplicantHowmedica Osteonics Corp.
Decision Date2000-12-18
Product CodeLXT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DYNAMIC JOINT DISTRACTOR II 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 2000-12-18 under 510(k) number K002923. 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 DYNAMIC JOINT DISTRACTOR II EXTERNAL FIXATION SYSTEM?

DYNAMIC JOINT DISTRACTOR II EXTERNAL FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2000-12-18. The listed applicant is Howmedica Osteonics Corp.. The 510(k) number is K002923.

When did DYNAMIC JOINT DISTRACTOR II EXTERNAL FIXATION SYSTEM receive FDA 510(k) clearance?

DYNAMIC JOINT DISTRACTOR II EXTERNAL FIXATION SYSTEM received FDA 510(k) clearance on 2000-12-18, under 510(k) number K002923.

Who is the listed applicant for DYNAMIC JOINT DISTRACTOR II 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 DYNAMIC JOINT DISTRACTOR II EXTERNAL FIXATION SYSTEM?

The FDA product code for DYNAMIC JOINT DISTRACTOR II EXTERNAL FIXATION SYSTEM is LXT.

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Related Devices (Code: LXT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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