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FDA 510(k)

MODUS IMF SCREWS 2.0

K-Number: K052061 · 2005-10-21

ApplicantMedartis, Inc.
Decision Date2005-10-21
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MODUS IMF SCREWS 2.0 is the device name listed in this FDA 510(k) record. The listed applicant is Medartis, Inc.. It received FDA 510(k) clearance on 2005-10-21 under 510(k) number K052061. 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 MODUS IMF SCREWS 2.0?

MODUS IMF SCREWS 2.0 is a medical device that received FDA 510(k) clearance on 2005-10-21. The listed applicant is Medartis, Inc.. The 510(k) number is K052061.

When did MODUS IMF SCREWS 2.0 receive FDA 510(k) clearance?

MODUS IMF SCREWS 2.0 received FDA 510(k) clearance on 2005-10-21, under 510(k) number K052061.

Who is the listed applicant for MODUS IMF SCREWS 2.0?

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

What is the FDA product code for MODUS IMF SCREWS 2.0?

The FDA product code for MODUS IMF SCREWS 2.0 is DZE.

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Other records listing Medartis, Inc. as applicant

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Related Devices (Code: DZE)

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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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