FDA.reportPublic FDA data

EPORE® XO

Primary DI
04048844711726
Brand
EPORE® XO
Company
implantcast GmbH
Model
0220805800
Device description
cup cementless
Published
2026-06-02
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
OQIHip, semi-constrained, cemented, metal/ceramic/polymer + additive, porous uncemented

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048844711726PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048844711726040488447117264048844711726

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Radiation Sterilization

Regulatory Flags#

DUNS number
324369826
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04048844017309NA258628052026-06-02
04048844708443EPORE® XO022080502026-06-02
04048844711597EPORE® XO022080622026-06-02
04048844711740EPORE® XO02208062002026-06-02
04048844711795EPORE® XO02208072002026-06-02
04048844711870EPORE® XO022090562026-06-02
04048844711917EPORE® XO02209048002026-06-02
04048844711955EPORE® XO02209056002026-06-02
04048844711979EPORE® XO022090602026-06-02
04048844712020EPORE® XO02209064002026-06-02
04048844712068EPORE® XO02209068002026-06-02
04048844712099EPORE® XO022090722026-06-02
04048844712723NA025632462026-06-02
04048844712747NA025636542026-06-02
04048844712761NA025636622026-06-02
04048844712785NA025640542026-06-02
04048844712808NA025640622026-06-02
04048844712822NA025828422026-06-02
04048844712846NA025836502026-06-02
04048844712860NA025836582026-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719886896602United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-10-15
04719886899030United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-10-15
04719886899047United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-10-15
04719886899054United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-10-15
04719886899061United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-10-15
04719886899078United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-10-15
04719886899085United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-10-15
04719886899092United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-10-15
04719886899108United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-10-15
04719886899115United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-10-15
04719886899122United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-10-15
04719886899139United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-10-15
04719886899146United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-10-15
04719886899153United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-10-15
04719886899160United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-10-15
04719886899177United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-10-15
04719886899184United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-10-15
04719886899191United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-10-15
04719886899207United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-10-15
04719886899214United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-10-15
04719886899221United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-10-15
04719886899238United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-10-15
04719886899245United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-10-15
04719886899252United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-10-15
04719886910896United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-10-15
04719886913361Momentum Acetabular Cup SystemUNITED ORTHOPEDIC CORP.OQI2026-10-15
04719886913378Momentum Acetabular Cup SystemUNITED ORTHOPEDIC CORP.OQI2026-10-15
04719886913385Momentum Acetabular Cup SystemUNITED ORTHOPEDIC CORP.OQI2026-10-15
04719886913392Momentum Acetabular Cup SystemUNITED ORTHOPEDIC CORP.OQI2026-10-15
04719886913408Momentum Acetabular Cup SystemUNITED ORTHOPEDIC CORP.OQI2026-10-15