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Femoral Head Ceramic
EUDAMEDFDA 510(k)Class III (EU MDR)
Ref BO76.3102.000.00Model Femoral Head Ceramic Biolox®Delta D.28 S
Identity
- Device Name
- Femoral Head Ceramic EUDAMED
- Model / Reference
- Femoral Head Ceramic Biolox®Delta D.28 S EUDAMEDBO76.3102.000.00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08050391091721 EUDAMED
- Basic UDI-DI
- B-08050391091721 EUDAMED
- Direct Marketing DI
- 08050391091721 EUDAMED
- EMDN Code
- P090804050201 CERAMIC FEMORAL HEADS, TOTAL HIP REPLACEMENT EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Ceramic femoral head prosthesis
Femoral Head Ceramic by Lincotek Bologna S.r.l — Class III — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — 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
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K082844 | Class III | Active |
| EUDAMED | European Union | CE/MDD | B-08050391091721 | Class III | Active |
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Manufacturer
- Manufacturer
- Lincotek Bologna S.r.l
- EUDAMED SRN
- IT-MF-000033944
Sources (2)
- EUDAMED d4883a14-76ed-4cbc-97cc-acbbd5e25e7e 61 fields · synced Jun 19, 2026
- FDA 510(k) K082844 1 fields · synced May 18, 2026