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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 a medical device manufactured by Zimmer GmbH. It received FDA 510(k) clearance on 2019-08-06 under approval 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. It is manufactured by Zimmer GmbH. The 510(k) number is K191781.

When was Wagner SL Revision Stem Lateral and Wagner Cone Prosthesis System approved by the FDA?

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

What company makes Wagner SL Revision Stem Lateral and Wagner Cone Prosthesis System?

Wagner SL Revision Stem Lateral and Wagner Cone Prosthesis System is manufactured by Zimmer GmbH.

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.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07616050 Evaluation of the Impact of Virtual Park on Training Motivation in Adult Patients NOT_YET_RECRUITING NCT07204925 Towards Efficient Personalization of Computerized Lower Limb Prostheses Via Reinforcement Learning in a Clinical Setup - Group 1 RECRUITING NCT05505513 Can an Array of Micro-electrodes Implanted in a Human Nerve Record Neural Signals and Provide Feedback? RECRUITING NCT05883202 Effect of the Abutment-Prosthesis Connection on Marginal Bone Loss and Gingival Sealing Around Dental Implants SUSPENDED NCT03153475 ATTUNE Revision System in the Revision Total Knee Arthroplasty Population ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 41612341 Brain-computer interface commercialization. Journal of neuroengineering and rehabilitation (2026)

Other Devices by Zimmer GmbH

K161620Anatomical Shoulder Domelock Dome centric K161192Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® System K160085Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder Fracture System K171858Sidus Stem-Free Shoulder K170711ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined System K170072Fitmore® Hip Stem

View all 19 devices →

Related Devices (Code: LZO)

K160895Initia Total Hip System & BIOCERAM AZUL(R) HEADKyocera Medical Corporation K161830Zimmer M/L Taper Hip ProsthesisZimmer, Inc. K161192Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® SystemZimmer GmbH K152893Corin Optimized Positioning System (OPS)Corin USA K160289MasterLoc StemMedacta International K152903REVIVAL(TM) Modular Revision Hip StemCorin USA

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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