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Biolox Delta
FDA UDIEUDAMEDClass III (US FDA UDI)
Ref 1365-28-210Model BIOLOX Delta 11/13 Taper Femoral Heads - Ceramic
Identity
- Trade Name
- BIOLOX DELTA EUDAMEDFDA UDI
- Generic Name
- Ceramic femoral head prosthesis FDA UDI
- Device Name
- 11/13 Taper Femoral Heads - Ceramic EUDAMEDBIOLOX DELTA CERAMIC FEMORAL HEAD Diameter 28mm +0 11/13 TAPER FDA UDI
- Model / Reference
- 1365-28-210 EUDAMEDFDA UDIBIOLOX Delta 11/13 Taper Femoral Heads - Ceramic EUDAMED
- Description
- BIOLOX DELTA CERAMIC FEMORAL HEAD Diameter 28mm +0 11/13 TAPER FDA UDI
Identifiers
- Catalog Number
- 136528210 FDA UDI
- Primary DI / UDI-DI
- 10603295033240 EUDAMEDFDA UDI
- Basic UDI-DI
- 0603295a0027997 EUDAMED
- FDA Product Code
- MRA FDA UDILZO 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 EUDAMEDFDA UDI
- Regulation Number
- 888.3353 FDA UDI
- Market of Registration
- Ireland 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
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
No
FDA UDI
Category: Ceramic femoral head prosthesis
Biolox Delta by Depuy Orthopaedics, Inc. — Class III — MDR, 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
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class III | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Depuy Orthopaedics, Inc.
Sources (2)
- FDA UDI 9c7a3e19-63a4-4cef-88a7-b487ebeae841 35 fields · synced Sep 17, 2026
- EUDAMED c6db68da-d93e-450d-8f40-fa6c9c75375f 61 fields · synced Sep 17, 2026