FDA.reportPublic FDA data

AGILON® XO Goniometer

Primary DI
04048844381226
Brand
AGILON® XO Goniometer
Company
implantcast GmbH
Model
78013000
Published
2022-09-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KQWGoniometer, Nonpowered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KQWGoniometer, NonpoweredOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048844381226PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048844381226040488443812264048844381226

GMDN Terms#

Term, Definition table
TermDefinition
Joint prosthesis implantation kit, reusableA collection of surgical instruments used for cutting and forming bone to allow the implantation of a joint prosthesis. The instruments include various metallic and/or plastic reusable devices (e.g., retractors, rods, clamps, drills, pins, saws, guides, cutting blocks) that are specific to the joint of application (e.g., hip, knee, shoulder, ankle, or elbow); the implant(s) is not included. This is a reusable device.

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
00889024706842mymobility® PlatformZimmer Us, Inc.KQW2026-03-10
00889024706859mymobility® PlatformZimmer Us, Inc.KQW2026-03-10
00889024706866mymobility® PlatformZimmer Us, Inc.KQW2026-03-10
00889024706873mymobility® PlatformZimmer Us, Inc.KQW2026-03-10
00889024706880mymobility® PlatformZimmer Us, Inc.KQW2026-03-10
00889024706897mymobility® PlatformZimmer Us, Inc.KQW2026-03-10
00889024694286mymobility® PlatformZimmer Us, Inc.KQW2025-05-23
00889024694316mymobility® PlatformZimmer Us, Inc.KQW2025-05-23
00889024694323mymobility® PlatformZimmer Us, Inc.KQW2025-05-23
00889024694330mymobility® PlatformZimmer Us, Inc.KQW2025-05-23
00889024680708mymobility® PlatformZimmer Us, Inc.KQW2024-11-05
00889024680739mymobility® PlatformZimmer Us, Inc.KQW2024-11-05
00889024680746mymobility® PlatformZimmer Us, Inc.KQW2024-11-05
00889024680753mymobility® PlatformZimmer Us, Inc.KQW2024-11-05
10889981319908Regatta® PlateSeaspine Orthopedics CorporationKQW2024-03-06
10889981319915Regatta® PlateSeaspine Orthopedics CorporationKQW2024-03-06
10889981319922Regatta® PlateSeaspine Orthopedics CorporationKQW2024-03-06
G586G95549410Novo SurgicalNOVO SURGICAL, INC.KQW2023-12-18
00087453152104JamarHYGENIC CORPORATION, THEKQW2023-12-07
10885914030445JamarHYGENIC CORPORATION, THEKQW2023-12-07
00887868581120mymobility® PlatformZimmer Us, Inc.KQW2023-09-07
00887868581151mymobility® PlatformZimmer Us, Inc.KQW2023-09-07
00887868581168mymobility® PlatformZimmer Us, Inc.KQW2023-09-07
00887868581175mymobility® PlatformZimmer Us, Inc.KQW2023-09-07
00816271020780myoRESEARCHNoraxon U.S.A., Inc.KQW2023-06-07
00860003118344CanarE – Clinic Wearable DeviceCanary Medical USA LLCKQW2023-05-17
00842962122624HNM MEDICALHNM STAINLESS, LLC.KQW2023-03-29
00887868574283mymobility® PlatformZimmer Us, Inc.KQW2023-03-16
00887868574290mymobility® PlatformZimmer Us, Inc.KQW2023-03-16
00887868574306mymobility® PlatformZimmer Us, Inc.KQW2023-03-16