FDA.reportPublic FDA data

MobileLink Acetabular Cup System

Primary DI
04026575177332
Brand
MobileLink Acetabular Cup System
Company
WALDEMAR LINK GmbH & Co. KG
Model
183-580/03
Device description
Shell/Insert Adapter; neutral; 0° inclination, 0 mm offset
Published
2023-01-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
OQGHip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedic2
OQGHip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200607000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200607000LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KG2021-05-28LPH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04026575177332PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04026575177332040265751773324026575177332

GMDN Terms#

Term, Definition table
TermDefinition
Acetabular shellAn implantable component of a two-piece acetabulum prosthesis that forms the outer portion of the prosthesis, fixed to the pelvis to provide a base for the inner portion (acetabular liner). It is made of metal, and is fixed with bone cement and/or fixation devices.

Regulatory Flags#

DUNS number
315675488
Device count
1
DM exempt
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04026575448678MobileLink Acetabular Cup System183-353/40183-353/402026-07-09
04026575448685MobileLink Acetabular Cup System183-363/40183-363/402026-07-09
04026575448760MobileLink Acetabular Cup System183-354/40183-354/402026-07-09
04026575448777MobileLink Acetabular Cup System183-355/40183-355/402026-07-09
04026575448784MobileLink Acetabular Cup System183-356/40183-356/402026-07-09
04026575448791MobileLink Acetabular Cup System183-364/40183-364/402026-07-09
04026575448807MobileLink Acetabular Cup System183-365/40183-365/402026-07-09
04026575448814MobileLink Acetabular Cup System183-366/40183-366/402026-07-09
04026575448821MobileLink Acetabular Cup System183-373/40183-373/402026-07-09
04026575448838MobileLink Acetabular Cup System183-374/40183-374/402026-07-09
04026575448845MobileLink Acetabular Cup System183-375/40183-375/402026-07-09
04026575448852MobileLink Acetabular Cup System183-376/40183-376/402026-07-09
04026575448869MobileLink Acetabular Cup System183-743/40183-743/402026-07-09
04026575448876MobileLink Acetabular Cup System183-744/40183-744/402026-07-09
04026575448883MobileLink Acetabular Cup System183-745/40183-745/402026-07-09
04026575448890MobileLink Acetabular Cup System183-746/40183-746/402026-07-09
04026575348213SPII Model Lubinus128-950/35128-950/352015-11-01
04026575348220SPII Model Lubinus128-951/35128-951/352015-11-01
04026575348237SPII Model Lubinus128-952/35128-952/352015-11-01
04026575348244SPII Model Lubinus128-953/35128-953/352015-11-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840097513201Velora Acetabular System InstrumentationRestor3d, Inc.LPH2026-08-21
00840097536675Velora Acetabular System InstrumentationRestor3d, Inc.LPH2026-08-19
10885862013743NAExactech, Inc.LPH2022-09-20
10885862013750NAExactech, Inc.LPH2022-09-20
10885862022448NAExactech, Inc.LPH2022-09-19
10885862022455NAExactech, Inc.LPH2022-09-19
10885862029867NAExactech, Inc.LPH2022-09-19
10885862010551NAExactech, Inc.LPH2022-08-18
10885862010575NAExactech, Inc.LPH2022-08-18
10885862010582NAExactech, Inc.LPH2022-08-18
10885862010872NAExactech, Inc.LPH2022-08-18
10885862010889NAExactech, Inc.LPH2022-08-18
10885862010896NAExactech, Inc.LPH2022-08-18
10885862016690NAExactech, Inc.LPH2022-08-18
10885862016706NAExactech, Inc.LPH2022-08-18
10885862016713NAExactech, Inc.LPH2022-08-18
10885862016720NAExactech, Inc.LPH2022-08-18
10885862016737NAExactech, Inc.LPH2022-08-18
10885862016744NAExactech, Inc.LPH2022-08-18
10885862016751NAExactech, Inc.LPH2022-08-18
10885862016768AcuMatchExactech, Inc.LPH2022-08-18
10885862016775AcuMatchExactech, Inc.LPH2022-08-18
10885862016782AcuMatchExactech, Inc.LPH2022-08-18
10885862016799AcuMatchExactech, Inc.LPH2022-08-18
10885862016805AcuMatchExactech, Inc.LPH2022-08-18
10885862016812AcuMatchExactech, Inc.LPH2022-08-18
10885862016829AcuMatchExactech, Inc.LPH2022-08-18
10885862016836AcuMatchExactech, Inc.LPH2022-08-18
10885862016843AcuMatchExactech, Inc.LPH2022-08-18
10885862016973AcuMatchExactech, Inc.LPH2022-08-18