FDA.reportPublic FDA data

MobileLink Acetabular Cup System

Primary DI
04026575175857
Brand
MobileLink Acetabular Cup System
Company
WALDEMAR LINK GmbH & Co. KG
Model
183-201/58
Device description
TrabecuLink Shell, Cluster Hole
Published
2023-04-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OQGHip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222066000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222066000LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG2023-04-14LPH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04026575175857PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04026575175857040265751758574026575175857

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315675488
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04026575175215Fusion Nail15-0028/0715-0028/072015-11-01
04026575175222Fusion Nail15-0028/0815-0028/082015-11-01
04026575346677Endo Model Knee Fusion Nail FK15-8429/2115-8429/212021-01-12
04026575346684Endo Model Knee Fusion Nail FK15-8429/2215-8429/222021-01-12
04026575346691Endo Model Knee Fusion Nail FK15-8429/2315-8429/232021-01-12
04026575346707Endo Model Knee Fusion Nail FK15-8430/2115-8430/212021-01-12
04026575346714Endo Model Knee Fusion Nail FK15-8430/2215-8430/222021-01-12
04026575346721Endo Model Knee Fusion Nail FK15-8430/2315-8430/232021-01-12
04026575346738Endo Model Knee Fusion Nail FK15-8431/2115-8431/212021-01-12
04026575346745Endo Model Knee Fusion Nail FK15-8431/2215-8431/222021-01-12
04026575346752Endo Model Knee Fusion Nail FK15-8431/2315-8431/232021-01-12
04026575048168General Instrument15-80352026-02-02
04026575080106MP Reconstruction System Instruments134-011/002026-02-02
04026575080175MP Reconstruction System Instruments134-031/002026-02-02
04026575080182General Instrument134-210/002026-02-02
04026575081011MP Reconstruction System - Instruments134-212/002026-02-02
04026575081042MP Reconstruction System Instruments134-041/002026-02-02
04026575081059MP Reconstruction System Instruments134-051/002026-02-02
04026575083183Endo-Model Knee System - Endo-Model EVO Knee System - LinkOptiStems151-01/012026-02-02
04026575083206Endo-Model Knee System - Endo-Model EVO Knee System - LinkOptiStems151-05/052026-02-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889024686595G7® Revision Acetabular SystemZimmer, Inc.OQG2026-02-10
00889024686601G7® Revision Acetabular SystemZimmer, Inc.OQG2026-02-10
00889024686618G7® Revision Acetabular SystemZimmer, Inc.OQG2026-02-10
00190446893349DJO SURGICALEncore Medical, L.P.OQG2025-12-04
00190446893363DJO SURGICALEncore Medical, L.P.OQG2025-12-04
00190446893370DJO SURGICALEncore Medical, L.P.OQG2025-12-04
00190446893387DJO SURGICALEncore Medical, L.P.OQG2025-12-04
00190446893400DJO SURGICALEncore Medical, L.P.OQG2025-12-04
00190446893424DJO SURGICALEncore Medical, L.P.OQG2025-12-04
00190446893431DJO SURGICALEncore Medical, L.P.OQG2025-12-04
00190446893448DJO SURGICALEncore Medical, L.P.OQG2025-12-04
00190446893486DJO SURGICALEncore Medical, L.P.OQG2025-12-04
08033390270267ArTTLIMACORPORATE SPAOQG2025-09-25
08033390270274ArTTLIMACORPORATE SPAOQG2025-09-25
08033390270281ArTTLIMACORPORATE SPAOQG2025-09-25
08033390270298ArTTLIMACORPORATE SPAOQG2025-09-25
08033390270304ArTTLIMACORPORATE SPAOQG2025-09-25
08033390270311ArTTLIMACORPORATE SPAOQG2025-09-25
08033390270328ArTTLIMACORPORATE SPAOQG2025-09-25
08033390270335ArTTLIMACORPORATE SPAOQG2025-09-25
08033390277211ArTTLIMACORPORATE SPAOQG2025-09-25
08033390277228ArTTLIMACORPORATE SPAOQG2025-09-25
08033390277235ArTTLIMACORPORATE SPAOQG2025-09-25
08033390277242ArTTLIMACORPORATE SPAOQG2025-09-25
08033390277259ArTTLIMACORPORATE SPAOQG2025-09-25
08033390286794ArTTLIMACORPORATE SPAOQG2025-09-25
08033390300315ArTTLIMACORPORATE SPAOQG2025-09-25
08033390300322ArTTLIMACORPORATE SPAOQG2025-09-25
08033390300339ArTTLIMACORPORATE SPAOQG2025-09-25
08033390300346ArTTLIMACORPORATE SPAOQG2025-09-25