Device name*4.5 mm Cortex Bone Screw
Intended purposeInternal fixation of bone fractures and osteotomies
UDI-DI*(01)08693000700012
Basic UDI-DI8693000CORTEX45YZ
Device typeimplant
GMDN code47957
CE marking*✓ Yes
Notified body0123 · CE 654321
EUDAMED registrationEUD-2026-0042
Manufacturer SRNCH-MF-000012345
Single use⊘ Yes
Latex-free✓ Yes
MR safetyMR Conditional
Shelf life60 months
Implant card✓ Yes
CMR / endocrine substances✗ No
Phthalates✗ No
MaterialsTi-6Al-4V ELI titanium alloy
CertificationsISO 13485 · ISO 14971
