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Sources: EU EUDAMED, US FDA
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Orthofix Srl
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🇮🇹 Italy
ORTHOFIX SRL
FDA registration
ORTHOFIX SRL·34 products·🇮🇹 Italy
Orthofix TrueLok Hexapod System (TL-HEX) V2.0
FDA 510(k)
FDA Class 2
·Orthopedic
Orthofix MJ-FLEX THE NEW METAIZEAU NAIL
FDA 510(k)
FDA Class 2
·Orthopedic
Orthofix True Lok Hexapod System VI.3
FDA 510(k)
FDA Class 2
·Orthopedic
ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System
FDA 510(k)
FDA Class 2
·Orthopedic
ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System
FDA 510(k)
FDA Class 2
·Orthopedic
Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4
FDA 510(k)
FDA Class 2
·Orthopedic
Orthofix Srl
Importer
🇮🇹 Italy
ORTHOFIX Catalogue Number: ref:99-93503 , ANKLE STERILE KIT, UDI: (01)18033509859922
FDA Enforcement
Class II
·Terminated·Orthofix Srl·November 20, 2019
ORTHOFIX Catalogue Number: ref: 99-93502US, TIBIA FEMUR DIAPHYSEAL STERILE KIT, UDI: (01)18054242S511298
FDA Enforcement
Class II
·Terminated·Orthofix Srl·November 20, 2019
ORTHOFIX Catalogue Number: ref: 99-93501US, PELVIS STERILE KIT, RX ONLY, UDI: (01)180S4242S11281
FDA Enforcement
Class II
·Terminated·Orthofix Srl·November 20, 2019
ORTHOFIX Catalogue Number: ref: 99-93503US, ANKLE TRANSFIX PIN STERILE KIT, UDI: (01)18054242511304
FDA Enforcement
Class II
·Terminated·Orthofix Srl·November 20, 2019
ORTHOFIX Catalogue Number: ref: 99-93504, ELBOW STERILE KIT, UDI: (01)18054242511533
FDA Enforcement
Class II
·Terminated·Orthofix Srl·November 20, 2019
ORTHOFIX Catalogue Number: ref: 99-93601, GALAXY WRIST STERILE KIT, UDI: (01)18054242511656
FDA Enforcement
Class II
·Terminated·Orthofix Srl·November 20, 2019
ORTHOFIX Catalogue Number: ref: 99-93501, PELVIS STERILE KIT, RX ONLY, UDI: (01)18033509859908
FDA Enforcement
Class II
·Terminated·Orthofix Srl·November 20, 2019
ORTHOFIX Catalogue Number: ref: 99-91647, US XCALIBER ANKLE COMPLETE KIT, RX ONLY, UDI: (01)18032937167791
FDA Enforcement
Class II
·Terminated·Orthofix Srl·November 20, 2019
ORTHOFIX Catalogue Number: ref 11007, drill bit diameter 4.8 MM LENGTH 280 MM, RX ONLY, Non Sterile, UDI: (01)18032568031959
FDA Enforcement
Class II
·Terminated·Orthofix Srl·November 20, 2019
ORTHOFIX Catalogue Number: ref: 99-93502, LOWER LIMB DIAPHYSEAL STERILE KIT, RX ONLY, UDI: (01)18033509859915
FDA Enforcement
Class II
·Terminated·Orthofix Srl·November 20, 2019
ORTHOFIX Catalogue Number: ref 1100101, drill bit diameter 4.8 MM LENGTH 180 MM, RX ONLY, Non Sterile, UDI: (01)18032568031867
FDA Enforcement
Class II
·Terminated·Orthofix Srl·November 20, 2019