FDA.report

MobileLink Acetabular Cup System

Primary DI
04026575175819
Brand
MobileLink Acetabular Cup System
Company
WALDEMAR LINK GmbH & Co. KG
Model
183-201/50
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

Related Records

Product Codes

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

Product Code Classifications

CodeDeviceSpecialtyClass
OQGHip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, UncementedOrthopedic2

Premarket Submissions

SubmissionSupplement
K222066000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K222066000LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG2023-04-14LPH

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04026575175819PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04026575175819040265751758194026575175819

GMDN Terms

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

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

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