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FDA 510(k)

MEDICON IMF-ORION SCREWS

K-Number: K050478 · 2005-06-15

ApplicantMedicon EG
Decision Date2005-06-15
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MEDICON IMF-ORION SCREWS is the device name listed in this FDA 510(k) record. The listed applicant is Medicon EG. It received FDA 510(k) clearance on 2005-06-15 under 510(k) number K050478. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDICON IMF-ORION SCREWS?

MEDICON IMF-ORION SCREWS is a medical device that received FDA 510(k) clearance on 2005-06-15. The listed applicant is Medicon EG. The 510(k) number is K050478.

When did MEDICON IMF-ORION SCREWS receive FDA 510(k) clearance?

MEDICON IMF-ORION SCREWS received FDA 510(k) clearance on 2005-06-15, under 510(k) number K050478.

Who is the listed applicant for MEDICON IMF-ORION SCREWS?

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

What is the FDA product code for MEDICON IMF-ORION SCREWS?

The FDA product code for MEDICON IMF-ORION SCREWS is DZE.

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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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