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Titanium Acetabular Screw
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 0601040Model TITANIUM ACETABULAR SCREW DIAM. 6,5 MM L. 40 MM
Identity
- Trade Name
- SCREW FOR CUP EUDAMEDTitanium Acetabular Screw FDA UDI
- Generic Name
- Orthopaedic bone screw (non-sliding) FDA UDI
- Device Name
- Titanium Acetabular Screw Diam. 6.5 mm L. 40 mm FDA UDI
- Model / Reference
- TITANIUM ACETABULAR SCREW DIAM. 6,5 MM L. 40 MM EUDAMED0601040 EUDAMEDAcetabular Screw FDA UDI
- Description
- Titanium Acetabular Screw Diam. 6.5 mm L. 40 mm FDA UDI
Identifiers
- Catalog Number
- 0601040 FDA UDI
- Primary DI / UDI-DI
- 08052532831975 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08052532831975 EUDAMED
- FDA Product Code
- LPH FDA UDIJDI FDA UDILZO FDA UDIMBL FDA UDI
- EMDN Code
- P09088007 HIP PROSTHESES FIXING SCREWS EUDAMED
- GMDN Term
- Orthopaedic bone screw (non-sliding) 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: Orthopaedic bone screw (non-sliding)
Titanium Acetabular Screw by Adler Ortho Spa — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone screw (non-sliding).
- EVOS — Smith & Nephew, Inc. · Class II
- TriLeap Lower Extremity Anatomic Plating System — CROSSROADS EXTREMITY SYSTEMS LLC · Class II
- Arthrex® — Arthrex, Inc. · Class II
- Zavation — ZAVATION · Class II
- STARDRIVE — Synthes GmbH · Class IIb
- Arthrex® — Arthrex, Inc. · Class II
- Cancellous Screw, Locking — I.T.S. GmbH · Class II
- PANGEA — Stryker Corp. · 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 8c1e6581-9fb5-4f42-9faf-2e09ab5672d2 35 fields · synced Jul 13, 2026
- EUDAMED e8f40a28-84d5-4c10-aac7-9af1a3c7d3ee 61 fields · synced Jul 13, 2026