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FDA 510(k)

LINK GEMINI SL Total Knee System

K-Number: K182872 · 2019-04-03

ApplicantWaldemar Link GmbH & Co. KG
Decision Date2019-04-03
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LINK GEMINI SL Total Knee System is a medical device manufactured by Waldemar Link GmbH & Co. KG. It received FDA 510(k) clearance on 2019-04-03 under approval number K182872. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LINK GEMINI SL Total Knee System?

LINK GEMINI SL Total Knee System is a medical device that received FDA 510(k) clearance on 2019-04-03. It is manufactured by Waldemar Link GmbH & Co. KG. The 510(k) number is K182872.

When was LINK GEMINI SL Total Knee System approved by the FDA?

LINK GEMINI SL Total Knee System received FDA 510(k) clearance on 2019-04-03, under approval number K182872.

What company makes LINK GEMINI SL Total Knee System?

LINK GEMINI SL Total Knee System is manufactured by Waldemar Link GmbH & Co. KG.

What is the FDA product code for LINK GEMINI SL Total Knee System?

The FDA product code for LINK GEMINI SL Total Knee System is JWH.

Related Clinical Trials

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Related PubMed Literature

PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026)

Other Devices by Waldemar Link GmbH & Co. KG

K152431LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx (TiNbN) coating K161840LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip System PoroLink® (microporous) and HX® (CaP) coated K171273LINK® BiMobile(TM) Dual Mobility System K192559Acetabular Bone Screws (for MobileLink Acetabular Cup System) K190535BiMobile Dual Mobility System - E-Dur Inserts K191755SPAR-K Instruments (for use with Gemini SL Total Knee System)

View all 29 devices →

Related Devices (Code: JWH)

K160515PS2 Knee SystemConsensus Orthopedics, Inc. K160771Destiknee Total Knee SystemMeril Healthcare Private Limited K160157LOSPA Modular Knee SystemCorentec Co., Ltd. K162273Materialise TKA Guide SystemMaterialise NV K162422Klassic Knee SystemTotal Joint Orthopedics, Inc. K161945EXPRT Revision Knee Femoral Augment(5mm), EXPRT Revision Knee Stem Extension (40mm)Encore Medical L.P.

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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