FDA.reportPublic FDA data

AGILON®

Primary DI
04048844620202
Brand
AGILON®
Company
implantcast GmbH
Model
78010175
Device description
XO drill for glenoid central screw
Published
2024-06-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
PHXShoulder Prosthesis, Reverse Configuration

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic UncementedOrthopedic2
PHXShoulder Prosthesis, Reverse ConfigurationOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048844620202PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048844620202040488446202024048844620202

GMDN Terms#

Term, Definition table
TermDefinition
Fluted surgical drill bit, reusableA shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is usually inserted into a surgical power tool or a surgical hand drill/brace. This is a reusable device.

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
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04048844007966n/a028200022026-05-06
04048844017293NA258628002026-05-06
04048844017316NA258628102026-05-06
04048844111250NA258640002026-05-06
04048844111267NA258640052026-05-06
04048844111274NA258640102026-05-06
04048844111281NA258640152026-05-06
04048844150228n/a028200402026-05-06
04048844708344EPORE® XO022080422026-05-06
04048844708375EPORE® XO022080442026-05-06
04048844708405EPORE® XO022080462026-05-06
04048844708429EPORE® XO022080482026-05-06
04048844708450EPORE® XO022080522026-05-06
04048844708467EPORE® XO022080542026-05-06
04048844711566EPORE® XO022080562026-05-06
04048844711573EPORE® XO022080582026-05-06
04048844711580EPORE® XO022080602026-05-06
04048844711603EPORE® XO022080642026-05-06
04048844711610EPORE® XO022080662026-05-06
04048844711627EPORE® XO022080682026-05-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B1132A2HI000100Shoulder Innovations InSet 95 Humeral StemShoulder Innovations, Inc.HSD2026-05-28
07613327668889Modular ElbowHowmedica Osteonics Corp.HSD2025-02-24
07613327668902Modular ElbowHowmedica Osteonics Corp.HSD2025-02-24
07613327668919Modular ElbowHowmedica Osteonics Corp.HSD2025-02-24
07613327668896Modular ElbowHowmedica Osteonics Corp.HSD2025-02-24
07613327603361REUNIONStryker GmbHHSD2024-10-01
07613327354379REUNIONStryker GmbHHSD2022-11-15
07613327354386REUNIONStryker GmbHHSD2022-11-15
07613327354799REUNIONStryker GmbHHSD2022-11-15
07613327354843REUNIONStryker GmbHHSD2022-11-15
07613327354850REUNIONStryker GmbHHSD2022-11-15
07613327354867REUNIONStryker GmbHHSD2022-11-15
07613327354874REUNIONStryker GmbHHSD2022-11-15
07613327354898REUNIONStryker GmbHHSD2022-11-15
07613327354980REUNIONStryker GmbHHSD2022-11-15
07613327355079REUNIONStryker GmbHHSD2022-11-15
07613327355116REUNIONStryker GmbHHSD2022-11-15
07613327355123REUNIONStryker GmbHHSD2022-11-15
07613327355147REUNIONStryker GmbHHSD2022-11-15
07613327355161REUNIONStryker GmbHHSD2022-11-15
07613327355192REUNIONStryker GmbHHSD2022-11-15
07613327355215REUNIONStryker GmbHHSD2022-11-15
07613327355239REUNIONStryker GmbHHSD2022-11-15
07613327355321REUNIONStryker GmbHHSD2022-11-15
07613327355352REUNIONStryker GmbHHSD2022-11-15
07613327355383REUNIONStryker GmbHHSD2022-11-15
07613327355451REUNIONStryker GmbHHSD2022-11-15
07613327354324REUNIONStryker GmbHHSD2022-11-14
07613327507096REUNIONStryker GmbHPHX2021-11-02
07613327354317REUNIONStryker GmbHPHX2021-04-27