Identity
- Trade Name
- AGILON® XO trial glenosphere FDA UDI
- Generic Name
- Reverse shoulder head prosthesis trial FDA UDI
- Model / Reference
- 78034046 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04048844426118 FDA UDI
- FDA Product Code
- PHX FDA UDIHSD FDA UDI
- GMDN Term
- Reverse shoulder head prosthesis trial FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3660 FDA UDI888.3690 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Reverse shoulder head prosthesis trial
AGILON® XO trial glenosphere by implantcast GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Reverse shoulder head prosthesis trial.
- Equinoxe — Exactech, Inc. · Class I
- ProMade Shoulder — Limacorporate · Class I
- Titan Reverse Shoulder System — Smith & Nephew, Inc. · Class I
- Comprehensive® Reverse Shoulder — Biomet Orthopedics, Inc. · Class II
- SMR Shoulder - Hybrid Glenoid — Limacorporate · Class II
- REUNION — Stryker Corp. · Class II
- Arthrex® — Arthrex, Inc. · Class II
- Equinoxe — Exactech, Inc. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- implantcast GmbH
Sources (1)
- FDA UDI e2c0abb5-59fc-4dff-b9c3-5cbf891a74e2 33 fields · synced Jun 6, 2026