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FDA 510(k)

LINK CEMENTLESS SCREW-IN ACETABULAR CUP

K-Number: K843940 · 1985-06-03

ApplicantWaldemar Link GmbH & Co. KG
Decision Date1985-06-03
Product CodeKWA
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LINK CEMENTLESS SCREW-IN ACETABULAR CUP 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 1985-06-03 under 510(k) number K843940. The device is classified under product code KWA. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LINK CEMENTLESS SCREW-IN ACETABULAR CUP?

LINK CEMENTLESS SCREW-IN ACETABULAR CUP is a medical device that received FDA 510(k) clearance on 1985-06-03. The listed applicant is Waldemar Link GmbH & Co. KG. The 510(k) number is K843940.

When did LINK CEMENTLESS SCREW-IN ACETABULAR CUP receive FDA 510(k) clearance?

LINK CEMENTLESS SCREW-IN ACETABULAR CUP received FDA 510(k) clearance on 1985-06-03, under 510(k) number K843940.

Who is the listed applicant for LINK CEMENTLESS SCREW-IN ACETABULAR CUP?

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 CEMENTLESS SCREW-IN ACETABULAR CUP?

The FDA product code for LINK CEMENTLESS SCREW-IN ACETABULAR CUP is KWA.

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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.

K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)K250375Allure Hip Stem and Intramedullary PlugsK243927MobileLink Acetabular Cup System - inhouse coatingsK241636MobileLink Acetabular Cup System - Line Extension (Multiple)K231445LINK Embrace Shoulder System - Reverse ConfigurationK222066LINK MobileLink Acetabular Cup System

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Related Devices (Code: KWA)

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.

K122778PROFEMUR Z REVISION HIP STEMWrightmedicaltechnologyincK121544DYNASTY BIOFOAM SHELLWrightmedicaltechnologyincK113271METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONSBiomet Manufacturing, Inc.K113322CONSERVE THIN SHELLWrightmedicaltechnologyincK112080PRESERVE HIP STEMWrightmedicaltechnologyincK112150PROFEMUR GLADIATOR HA HIP STEMWrightmedicaltechnologyinc

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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