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FDA 510(k)

Wagner SL Revision Stem Lateral and Wagner Cone Prosthesis System

K-Number: K191781 · 2019-08-06

ApplicantZimmer GmbH
Decision Date2019-08-06
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Wagner SL Revision Stem Lateral and 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 2019-08-06 under 510(k) number K191781. 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 SL Revision Stem Lateral and Wagner Cone Prosthesis System?

Wagner SL Revision Stem Lateral and Wagner Cone Prosthesis System is a medical device that received FDA 510(k) clearance on 2019-08-06. The listed applicant is Zimmer GmbH. The 510(k) number is K191781.

When did Wagner SL Revision Stem Lateral and Wagner Cone Prosthesis System receive FDA 510(k) clearance?

Wagner SL Revision Stem Lateral and Wagner Cone Prosthesis System received FDA 510(k) clearance on 2019-08-06, under 510(k) number K191781.

Who is the listed applicant for Wagner SL Revision Stem Lateral and 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 SL Revision Stem Lateral and Wagner Cone Prosthesis System?

The FDA product code for Wagner SL Revision Stem Lateral and Wagner Cone Prosthesis System is LZO.

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.

PMA P060037Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearingK261683Augment Off-Axis Instrument SystemK260831Z1 Hip SystemK251840Zimmer® Persona® Personalized Knee SystemK260182Avenir® Müller Stem; Avenir Complete™ Hip SystemK253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)

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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.

K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KGK260831Z1 Hip SystemZimmer, Inc.K260182Avenir® Müller Stem; Avenir Complete™ Hip SystemZimmer, Inc.K260037implantcast Packaging System UpdateImplantcast GmbHK252401implaFit® short stemsImplantcast GmbHK253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc.

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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