Identity
- Trade Name
- AGILON® XO cap FDA UDI
- Generic Name
- Stem-fixed metallic humeral head prosthesis FDA UDI
- Model / Reference
- 38605317 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04048844400545 FDA UDI
- FDA Product Code
- HSD FDA UDI
- GMDN Term
- Stem-fixed metallic humeral head prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3690 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Stem-fixed metallic humeral head prosthesis
AGILON® XO cap by implantcast GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Stem-fixed metallic humeral head prosthesis.
- MRS — Howmedica Osteonics Corp. · Class II
- FLEX SHOULDER SYSTEM — TORNIER, INC. · Class II
- FLEX SHOULDER SYSTEM — TORNIER, INC. · Class II
- GLOBAL ADVANTAGE — DEPUY ORTHOPAEDICS, INC. · Class II
- FLEX SHOULDER SYSTEM — TORNIER, INC. · Class II
- PERFORM™ HUMERAL SYSTEM — TORNIER, INC. · Class II
- Equinoxe — Exactech, Inc. · Class II
- TORNIER PERFORM™ HUMERAL SYSTEM — TORNIER, INC. · Class II
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 f50c5fe8-475d-438c-a2c5-c9f4dfc8ab02 33 fields · synced May 30, 2026