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Femoral Head CoCr
EUDAMEDClass III (EU MDR)
Ref BO76.1688.000.00Model Femoral Head CoCrMo D.22 SRef BO76.1691.000.00Model Femoral Head CoCrMo D.28 MRef BO76.1690.000.00Model Femoral Head CoCrMo D.28 SRef BO76.1696.000.00Model Femoral Head CoCrMo D.32 MRef BO76.1689.000.00Model Femoral Head CoCrMo D.22 MRef BO76.1699.000.00Model Femoral Head CoCrMo D.36 SRef BO76.1695.000.00Model Femoral Head CoCrMo D.32 SRef BO76.1697.000.00Model Femoral Head CoCrMo D.32 LRef BO76.1702.000.00Model Femoral Head CoCrMo D.36 XL
Identity
- Device Name
- Femoral Head CoCr EUDAMED
- Model / Reference
- Femoral Head CoCrMo D.22 S EUDAMEDBO76.1688.000.00 EUDAMEDFemoral Head CoCrMo D.28 M EUDAMEDBO76.1691.000.00 EUDAMEDFemoral Head CoCrMo D.28 S EUDAMEDBO76.1690.000.00 EUDAMEDFemoral Head CoCrMo D.32 M EUDAMEDBO76.1696.000.00 EUDAMEDFemoral Head CoCrMo D.22 M EUDAMEDBO76.1689.000.00 EUDAMEDFemoral Head CoCrMo D.36 S EUDAMEDBO76.1699.000.00 EUDAMEDFemoral Head CoCrMo D.32 S EUDAMEDBO76.1695.000.00 EUDAMEDFemoral Head CoCrMo D.32 L EUDAMEDBO76.1697.000.00 EUDAMEDFemoral Head CoCrMo D.36 XL EUDAMEDBO76.1702.000.00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08050507910007 EUDAMED08050507910038 EUDAMED08050507910021 EUDAMED08050507910083 EUDAMED08050507910014 EUDAMED08050507910113 EUDAMED08050507910076 EUDAMED08050507910090 EUDAMED08050507910144 EUDAMED
- Basic UDI-DI
- B-08050507910007 EUDAMEDB-08050507910038 EUDAMEDB-08050507910021 EUDAMEDB-08050507910083 EUDAMEDB-08050507910014 EUDAMEDB-08050507910113 EUDAMEDB-08050507910076 EUDAMEDB-08050507910090 EUDAMEDB-08050507910144 EUDAMED
- Direct Marketing DI
- 08050507910007 EUDAMED08050507910038 EUDAMED08050507910021 EUDAMED08050507910083 EUDAMED08050507910014 EUDAMED08050507910113 EUDAMED08050507910076 EUDAMED08050507910090 EUDAMED08050507910144 EUDAMED
- EMDN Code
- P090804050202 METAL 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: Metallic femoral head prosthesis
Femoral Head CoCr by Lincotek Bologna S.r.l — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Metallic femoral head prosthesis.
- Normmed CoCr Femoral Head 28 +12 — NORMMED MEDİKAL SAN. VE TİC. A.Ş. · Class III
- Consensus Hip System — SHALBY ADVANCED TECHNOLOGIES, INC. · Class II
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- Orthinox — Howmedica Osteonics Corp. · Class II
- A110212031 — EUROS SAS · Class III
- Consensus Hip System — SHALBY ADVANCED TECHNOLOGIES, INC. · Class II
- BIOMET HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
- Femoral Head — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08050507910007 | Class III | Active |
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Manufacturer
- Manufacturer
- Lincotek Bologna S.r.l
- EUDAMED SRN
- IT-MF-000033944
Sources (9)
- EUDAMED 295a54e0-b525-46fa-928b-48d021c7c445 61 fields · synced Oct 6, 2026
- EUDAMED 8dd05fd5-be96-4acc-b2f6-9d93a836d663 61 fields · synced May 17, 2026
- EUDAMED 8abe306e-1861-448b-9b8b-f20db9b3c9ac 61 fields · synced May 17, 2026
- EUDAMED af46b42f-943f-4fd5-862a-042e6355be9f 61 fields · synced May 17, 2026
- EUDAMED 106209e5-7d3a-43df-a2d3-9dca27ae5482 61 fields · synced May 18, 2026
- EUDAMED d1e737c7-d6a8-403b-993a-05a588d30d40 61 fields · synced May 18, 2026
- EUDAMED 84f0e700-a564-43ca-b84c-73aed30e92f9 61 fields · synced May 18, 2026
- EUDAMED 979c4157-3246-4cc1-a533-49763521ccdd 61 fields · synced May 18, 2026
- EUDAMED 7b645d39-1f0f-4a4c-b9a1-d51a1ccbc5a1 61 fields · synced May 19, 2026