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
04719886896466United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-09-24
04719886896473United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-09-24
04719886896480United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-09-24
04719886896497United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-09-24
04719886896503United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-09-24
04719886896510United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-09-24
04719886896527United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-09-24
04719886896534United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-09-24
04719886896541United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-09-24
04719886896558United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-09-24
04719886896565United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-09-24
04719886896572United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-09-24
04719886896589United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-09-24
04719886896596United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-09-24
04719886896633United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-09-24
04719886896640United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-09-24
04719886896657United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-09-24
04719886896664United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-09-24
04719886896671United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-09-24
04719886896688United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-09-24
04719886896695United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-09-24
04719886896701United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-09-24
04719886896718United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-09-24
04719886896725United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-09-24
04719886896732United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-09-24
04719886896749United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-09-24
04719886896756United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-09-24
04719886896763United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-09-24
04719886896770United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-09-24
04719886896787United Hip SystemUNITED ORTHOPEDIC CORP.OQI2026-09-24