FDA.reportPublic FDA data

EPORE® XO

Primary DI
04048844711597
Brand
EPORE® XO
Company
implantcast GmbH
Model
02208062
Device description
cup cementless incl. central hole cover
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
04048844711597PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048844711597040488447115974048844711597

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
true
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
04048844711726EPORE® XO02208058002026-06-02
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
00193982895006TRIVANCEGLOBUS MEDICAL, INC.OQI2026-08-14
00193982895013TRIVANCEGLOBUS MEDICAL, INC.OQI2026-08-14
00193982895020TRIVANCEGLOBUS MEDICAL, INC.OQI2026-08-14
00193982895037TRIVANCEGLOBUS MEDICAL, INC.OQI2026-08-14
00193982895044TRIVANCEGLOBUS MEDICAL, INC.OQI2026-08-14
00193982895051TRIVANCEGLOBUS MEDICAL, INC.OQI2026-08-14
00193982895068TRIVANCEGLOBUS MEDICAL, INC.OQI2026-08-14
00193982895075TRIVANCEGLOBUS MEDICAL, INC.OQI2026-08-14
00193982895082TRIVANCEGLOBUS MEDICAL, INC.OQI2026-08-14
00193982895099TRIVANCEGLOBUS MEDICAL, INC.OQI2026-08-14
00193982895105TRIVANCEGLOBUS MEDICAL, INC.OQI2026-08-14
00193982895112TRIVANCEGLOBUS MEDICAL, INC.OQI2026-08-14
00193982895136TRIVANCEGLOBUS MEDICAL, INC.OQI2026-08-14
00193982895143TRIVANCEGLOBUS MEDICAL, INC.OQI2026-08-14
00193982895150TRIVANCEGLOBUS MEDICAL, INC.OQI2026-08-14
00193982895167TRIVANCEGLOBUS MEDICAL, INC.OQI2026-08-14
00193982895174TRIVANCEGLOBUS MEDICAL, INC.OQI2026-08-14
00193982895181TRIVANCEGLOBUS MEDICAL, INC.OQI2026-08-14
00193982895198TRIVANCEGLOBUS MEDICAL, INC.OQI2026-08-14
00193982895204TRIVANCEGLOBUS MEDICAL, INC.OQI2026-08-14
00193982895211TRIVANCEGLOBUS MEDICAL, INC.OQI2026-08-14
00193982895228TRIVANCEGLOBUS MEDICAL, INC.OQI2026-08-14
00193982895235TRIVANCEGLOBUS MEDICAL, INC.OQI2026-08-14
00193982895242TRIVANCEGLOBUS MEDICAL, INC.OQI2026-08-14
00193982895266TRIVANCEGLOBUS MEDICAL, INC.OQI2026-08-14
00193982895273TRIVANCEGLOBUS MEDICAL, INC.OQI2026-08-14
00193982895280TRIVANCEGLOBUS MEDICAL, INC.OQI2026-08-14
00193982895297TRIVANCEGLOBUS MEDICAL, INC.OQI2026-08-14
00193982895303TRIVANCEGLOBUS MEDICAL, INC.OQI2026-08-14
00193982895310TRIVANCEGLOBUS MEDICAL, INC.OQI2026-08-14