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Sources: EU EUDAMED, US FDA
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SPINAL ELEMENTS, INC.
FDA registration
SPINAL ELEMENTS, INC.·29 products·🇺🇸 United States
Spinal Elements Navigated Instruments
FDA 510(k)
FDA Class 2
·Neurology
SPINAL ELEMENTS CERCLAGE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Spinal Elements Cerclage System
FDA 510(k)
FDA Class 2
·Orthopedic
Prosthesis, Posterior Spinal Elements
FDA Pre-Market Approval
FDA Class 3
·TOPS System
Prosthesis, Posterior Spinal Elements
FDA Pre-Market Approval
FDA Class 3
·TOPS System
Prosthesis, Posterior Spinal Elements
FDA Pre-Market Approval
FDA Class 3
·TOPS System
Prosthesis, Posterior Spinal Elements
FDA Pre-Market Approval
FDA Class 3
·TOPS System
Prosthesis, Posterior Spinal Elements
FDA Pre-Market Approval
FDA Class 3
·TOPS System
Prosthesis, Posterior Spinal Elements
FDA Pre-Market Approval
FDA Class 3
·TOPS System
Prosthesis, Posterior Spinal Elements
FDA Pre-Market Approval
FDA Class 3
·TOPS System
Prosthesis, Posterior Spinal Elements
FDA Pre-Market Approval
FDA Class 3
·TOPS System
Prosthesis, Posterior Spinal Elements
FDA Pre-Market Approval
FDA Class 3
·TOPS System
Prosthesis, Posterior Spinal Elements
FDA Pre-Market Approval
FDA Class 3
·TOPS System
Prosthesis, Posterior Spinal Elements
FDA Pre-Market Approval
FDA Class 3
·TOPS System
SPINAL ELEMENTS POSTERIOR CERVICAL/THORACIC SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SAVANNAH-T
FDA UDI
SPINAL ELEMENTS·00840916102807·Savannah®-T Low-Top Non-Cannulated Screw Assem...
PIRANHA
FDA UDI
SPINAL ELEMENTS·00840916112608·Piranha Cervical Screw Ø 4.25mm x 16mm
OVERWATCH
FDA UDI
SPINAL ELEMENTS·00840916132521·Overwatch® 9.5MM x 70MM Sagittal Reduction Screw
Venus
FDA UDI
SPINAL ELEMENTS·00840916118587·Venus Cervical Plate, Three Level, 74mm