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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 the device name listed in this FDA 510(k) record. The listed applicant is Waldemar Link GmbH & Co. KG. It received FDA 510(k) clearance on 2019-04-03 under 510(k) 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. The listed applicant is Waldemar Link GmbH & Co. KG. The 510(k) number is K182872.

When did LINK GEMINI SL Total Knee System receive FDA 510(k) clearance?

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

Who is the listed applicant for LINK GEMINI SL Total Knee System?

The FDA 510(k) record lists Waldemar Link GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Waldemar Link GmbH & Co. KG 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: JWH)

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.

K261563Freedom Total Knee System (E-Poly Tibial Liners)Maxx Orthopedics, Inc.K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.K261734Klassic Infection Spacer SystemTotal Joint Orthopedics, Inc.K261458ATTUNE Total Knee System; ATTUNE Cementless Knee SystemDePuy Ireland UCK261032NovoKnee (SteriKnee)NovoSourceK253793Materialise TKA Guide SystemMaterialise NV

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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