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Delta Alumina Ceramic Heads Morse Taper 12/14
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 0514363Model DELTA ALUMINA CERAMIC HEAD 12/14 DIAM 36 LONG
Identity
- Trade Name
- CERAMIC HEADS EUDAMEDDelta Alumina Ceramic Heads Morse Taper 12/14 FDA UDI
- Generic Name
- Ceramic femoral head prosthesis FDA UDI
- Device Name
- Delta Alumina Ceramic Head Ø36mm (Long) FDA UDI
- Model / Reference
- DELTA ALUMINA CERAMIC HEAD 12/14 DIAM 36 LONG EUDAMED0514363 EUDAMEDFemoral Head FDA UDI
- Description
- Delta Alumina Ceramic Head Ø36mm (Long) FDA UDI
Identifiers
- Catalog Number
- 0514363 FDA UDI
- Primary DI / UDI-DI
- 08052532831326 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08052532831326 EUDAMED
- FDA Product Code
- LPH FDA UDIJDI FDA UDILZO FDA UDIMBL FDA UDI
- EMDN Code
- P090804050201 CERAMIC FEMORAL HEADS, TOTAL HIP REPLACEMENT EUDAMED
- GMDN Term
- Ceramic femoral head prosthesis FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3358 FDA UDI888.3350 FDA UDI888.3353 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Category: Ceramic femoral head prosthesis
Delta Alumina Ceramic Heads Morse Taper 12/14 by Adler Ortho Spa — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Ceramic femoral head prosthesis.
- Ceramic ball head — Beijing LiDaKang Technology Co., Ltd. · Class III
- ELEC(R)plus — HiPer Medical AG · Class III
- BIOLOX® delta Modular Ceramic Head — Biomet Uk Ltd · Class II
- InSitu Hip System — Nextstep Arthropedix · Class II
- Prosthesis Head A — WALDEMAR LINK GmbH & Co. KG · Class II
- InSitu Hip System — Nextstep Arthropedix · Class II
- SYNERGY — Smith & Nephew, Inc. · Class II
- DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Adler Ortho Spa
Sources (2)
- FDA UDI 71dbff9d-f1f0-4e24-bad4-c5abb41a4984 35 fields · synced Oct 6, 2026
- EUDAMED e1e4426b-e83d-447e-9a37-72ca6e597f78 61 fields · synced Oct 5, 2026