7 results
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20ms
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Sources: EU EUDAMED, US FDA
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Country: Canada
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QC CAP
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PHOENIX 3.25 MM C.P. COATED DENTAL IMPLANT
FDA 510(k)
FDA Class 2
·Dental
CAP DRIVER
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·OrthoPediatrics Canada ULC·1 device
IMPACTION CAP
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·OrthoPediatrics Canada ULC·1 device
CAP DRIVER
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·OrthoPediatrics Canada ULC·1 device
EMPTY CAP CADDY
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·OrthoPediatrics Canada ULC·1 device
GAP Nail 4.8mm (diameter size) of the GAP ENDO-EXO MEDULLARY SYSTEM. Catalog number GAP-N48-16; GAP-N48-18; GAP-N48-26; GAP-N48-28. Product Usage: The GAP Endo-Exo Medullary System is used for the treatment of fractures or correction of deformities in the femur, tibia and humerus of pediatric patients, who have reached skeletal maturity. The GAP Nail is an intramedullary nail. It is the main component of the GAP Endo-Exo Medullary System. The rest of the components of the system are screws, plates and caps that are assembled to the nail during the surgical procedure. The GAP Endo-Exo Medullary System is indicated as a temporary implant to assure alignment, stabilization and fixation of: long bones that have been surgically prepared (osteotomy) for correction of deformities or fractures caused by trauma or disease. The GAP System is used for pediatric patients (child and adolescent) ages 2 to 21. It can be used to correct the following conditions: -Diaphyseal fracture of the femur, tibia and humerus -Fractures of the femoral neck -Subtrochanteric, intertrochanteric and combination fractures -Correction of deformities (OI, Coxa vara, Coxa valga) -Nonunions and malunions
FDA Enforcement
Class II
·Terminated·Pega Medical Inc.·April 8, 2015