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FDA 510(k)

Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® System

K-Number: K161192 · 2016-07-08

ApplicantZimmer GmbH
Decision Date2016-07-08
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® System is a medical device manufactured by Zimmer GmbH. It received FDA 510(k) clearance on 2016-07-08 under approval number K161192. 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, Wagner Cone Prosthesis® System?

Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® System is a medical device that received FDA 510(k) clearance on 2016-07-08. It is manufactured by Zimmer GmbH. The 510(k) number is K161192.

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

Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® System received FDA 510(k) clearance on 2016-07-08, under approval number K161192.

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

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

What is the FDA product code for Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® System?

The FDA product code for Wagner SL Revision Stem Lateral, 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

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Related Devices (Code: LZO)

K160895Initia Total Hip System & BIOCERAM AZUL(R) HEADKyocera Medical Corporation K161830Zimmer M/L Taper Hip ProsthesisZimmer, Inc. K152893Corin Optimized Positioning System (OPS)Corin USA K160289MasterLoc StemMedacta International K152903REVIVAL(TM) Modular Revision Hip StemCorin USA K152530UCP StemUnited Orthopedic Corporation

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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