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Locking Screw Ø5 x 75mm
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref LS02-50075
by OrthoXel DAC
Identity
- Trade Name
- Locking Screw Ø5 x 75mm EUDAMEDApex FDA UDI
- Generic Name
- Orthopaedic bone screw, non-bioabsorbable, sterile FDA UDI
- Device Name
- Locking Screw Ø5 x 75mm EUDAMED05 X 75MM FDA UDI
- Model / Reference
- LS02-50075 EUDAMEDFDA UDI
- Description
- 05 X 75MM FDA UDI
Identifiers
- Catalog Number
- LS02-50075 FDA UDI
- Primary DI / UDI-DI
- 05391529583446 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05391529583446 EUDAMED
- 510(k) Number
- K170972 FDA UDI
- FDA Product Code
- HWC FDA UDI
- EMDN Code
- P09120201 INTRAMEDULLARY NAILS 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
- 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Locking Screw Ø5 x 75mm by OrthoXel DAC — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05391529583446 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- OrthoXel DAC
- EUDAMED SRN
- IE-MF-000000574
Sources (2)
- EUDAMED ca6dc3bf-4904-4310-9f50-049667199519 61 fields · synced Jun 19, 2026
- FDA UDI 294ac260-7726-4569-9bf7-27c30597eaf3 38 fields · synced May 30, 2026