Acetabular Bone Screws (for MobileLink Acetabular Cup System)

Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

Waldemar Link GmbH & Co. KG

The following data is part of a premarket notification filed by Waldemar Link Gmbh & Co. Kg with the FDA for Acetabular Bone Screws (for Mobilelink Acetabular Cup System).

Pre-market Notification Details

Device IDK192559
510k NumberK192559
Device Name:Acetabular Bone Screws (for MobileLink Acetabular Cup System)
ClassificationProsthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Applicant Waldemar Link GmbH & Co. KG Oststraße 4-10 Norderstedt,  DE 22844
ContactKaren Sonnenberger
CorrespondentTerry Powell
LinkBio Corp. 69 King Street Dover,  NJ  07801
Product CodeLZO  
Subsequent Product CodeLPH
Subsequent Product CodeMEH
Subsequent Product CodeOQG
CFR Regulation Number888.3353 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-17
Decision Date2019-12-21

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04026575427437 K192559 000
04026575273768 K192559 000
04026575273775 K192559 000
04026575273782 K192559 000
04026575273799 K192559 000
04026575273805 K192559 000
04026575427376 K192559 000
04026575427390 K192559 000
04026575427406 K192559 000
04026575427413 K192559 000
04026575427420 K192559 000
04026575273751 K192559 000

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