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FDA 510(k)

WAGNER CONE PROSTHESIS SYSTEM

K-Number: K113556 · 2012-02-17

ApplicantZimmer GmbH
Decision Date2012-02-17
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

WAGNER CONE PROSTHESIS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer GmbH. It received FDA 510(k) clearance on 2012-02-17 under 510(k) number K113556. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WAGNER CONE PROSTHESIS SYSTEM?

WAGNER CONE PROSTHESIS SYSTEM is a medical device that received FDA 510(k) clearance on 2012-02-17. The listed applicant is Zimmer GmbH. The 510(k) number is K113556.

When did WAGNER CONE PROSTHESIS SYSTEM receive FDA 510(k) clearance?

WAGNER CONE PROSTHESIS SYSTEM received FDA 510(k) clearance on 2012-02-17, under 510(k) number K113556.

Who is the listed applicant for WAGNER CONE PROSTHESIS SYSTEM?

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

What is the FDA product code for WAGNER CONE PROSTHESIS SYSTEM?

The FDA product code for WAGNER CONE PROSTHESIS SYSTEM is LZO.

Related Clinical Trials

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.

Other records listing Zimmer GmbH as applicant

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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Related Devices (Code: LZO)

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.

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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