FDA.reportPublic FDA data

AGILON® XO trial glenoid

Primary DI
04048844546588
Brand
AGILON® XO trial glenoid
Company
implantcast GmbH
Model
78020043
Published
2022-11-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HWTTemplate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWTTemplateOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048844546588PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048844546588040488445465884048844546588

GMDN Terms#

Term, Definition table
TermDefinition
Humeral head prosthesis trial, reusableA copy of a final humeral head prosthesis designed to be used before primary or revision implant surgery to validate the proper size of the permanent prosthesis required by the patient, to ensure its proper orientation and positioning, and to verify that the implant site has been cut to the proper dimensions. It has a cup-like ball shape and is available in types such as concentric head fixation, eccentric head fixation, cuff tear arthropathy (CTA), or types for revision surgery. It is typically made of metal and/or polymer. This is a reusable device intended to be sterilized prior to use.

Device Sizes#

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

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
324369826
Device count
1
Premarket exempt
true
Lot or batch
true
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260056885877InterSpace® Hip Mold Trial Short StemOSARTIS GmbHHWT2026-10-29
04260056885891InterSpace® Hip Mold Trial Short StemOSARTIS GmbHHWT2026-10-29
04260056885914InterSpace® Hip Mold Trial Short StemOSARTIS GmbHHWT2026-10-29
04260056885938InterSpace® Hip Mold Trial Long StemOSARTIS GmbHHWT2026-10-29
04260056885952InterSpace® Hip Mold Trial Long StemOSARTIS GmbHHWT2026-10-29
04260056885976InterSpace® Hip Mold Trial Long StemOSARTIS GmbHHWT2026-10-29
04260056885990InterSpace® Hip Mold Trial Head 42 mmOSARTIS GmbHHWT2026-10-29
04260056886010InterSpace® Hip Mold Trial Head 48 mmOSARTIS GmbHHWT2026-10-29
04260056886034InterSpace® Hip Mold Trial Head 52 mmOSARTIS GmbHHWT2026-10-29
04260056886058InterSpace® Hip Mold Trial Head 56 mmOSARTIS GmbHHWT2026-10-29
04260056886072InterSpace® Hip Mold Trial Head 60 mmOSARTIS GmbHHWT2026-10-29
04260056886096InterSpace® Knee Mold Trial Femoral Component XSOSARTIS GmbHHWT2026-10-29
04260056886119InterSpace® Knee Mold Trial Femoral Component SOSARTIS GmbHHWT2026-10-29
04260056886133InterSpace® Knee Mold Trial Femoral Component MOSARTIS GmbHHWT2026-10-29
04260056886157InterSpace® Knee Mold Trial Femoral Component LOSARTIS GmbHHWT2026-10-29
04260056886171InterSpace® Knee Mold Trial Femoral Component XLOSARTIS GmbHHWT2026-10-29
04260056886195InterSpace® Knee Mold Trial Tibial Component XSOSARTIS GmbHHWT2026-10-29
04260056886218InterSpace® Knee Mold Trial Tibial Component SOSARTIS GmbHHWT2026-10-29
04260056886232InterSpace® Knee Mold Trial Tibial Component MOSARTIS GmbHHWT2026-10-29
04260056886256InterSpace® Knee Mold Trial Tibial Component LOSARTIS GmbHHWT2026-10-29
04260056886270InterSpace® Knee Mold Trial Tibial Component XLOSARTIS GmbHHWT2026-10-29
04260056886287InterSpace® Knee Mold Trial Tibial StemOSARTIS GmbHHWT2026-10-29
04260056886416InterSpace® Knee Mold Trial Tibial InsertOSARTIS GmbHHWT2026-10-29
04260056886423InterSpace® Knee Mold Trial Tibial Stemmed InsertOSARTIS GmbHHWT2026-10-29
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