Identity
- Trade Name
- VR Ø 2.7 x 11 EUDAMEDBRM VR Breaking Titanium Screw FDA UDI
- Generic Name
- Orthopaedic bone screw, non-bioabsorbable, sterile FDA UDI
- Device Name
- Viti per osteosintesi EUDAMED
- Model / Reference
- SRO127011S EUDAMED2.7x11 mm - Sterile FDA UDI
Identifiers
- Catalog Number
- SRO127011S FDA UDI
- Primary DI / UDI-DI
- 08057717551860 EUDAMEDFDA UDI
- Basic UDI-DI
- 805771755FT05FZ EUDAMED
- 510(k) Number
- K203773 FDA UDI
- FDA Product Code
- HWC FDA UDI
- EMDN Code
- P09120699 BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER EUDAMED
- GMDN Term
- Orthopaedic bone screw, non-bioabsorbable, sterile FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3040 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
Sutures
Yes
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
Dimensions & Sizes
- Size
- Length — 11 Millimeter FDA UDIOuter Diameter — 2.7 Millimeter FDA UDI
VR Ø 2.7 x 11 by BRM Extremities S.r.l. — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 805771755FT05FZ | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- BRM Extremities S.r.l.
- EUDAMED SRN
- IT-MF-000016087
Sources (2)
- EUDAMED 39d99851-4e9c-4841-a057-99bd19a92f73 61 fields · synced Jun 19, 2026
- FDA UDI 242ac653-40ea-4710-b728-e332abd43794 37 fields · synced May 25, 2026