Vendor/Manufacturer: Spineart
Product/Product Line: ROMEO® 2 Posterior Osteosynthesis System
FDA Regulation Medical Specialty: Orthopedic Devices - Prosthetic Devices
FDA Regulation Number: 888.3070
FDA Regulation Description Classification Name:
Pedicle Screw Spinal System
FDA Classification Product Code: NKB
FDA Classification Product Code Device Name:
Thoracolumbosacral Pedicle Screw System
SUBSTANTIALLY EQUIVALENT to the following products:
Device Description:
The ROMEO® 2 Posterior Osteosynthesis System comprises polyaxial screws, monoaxial screws, spondylolisthesis screws, setscrew, straight and pre-bent Titanium or CoCr rods, and various connectors available in several sizes and models to accommodate different patient anatomies. ROMEO® implantable components are single-use device provided sterile (gamma radiation) and supplied with dedicated surgical instruments.
The ROMEO® 2 Posterior Osteosynthesis System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). When used for posterior non-cervical pedicle screw fixation in pediatric patients, the ROMEO®2 Posterior Osteosynthesis System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The ROMEO®2 Posterior Osteosynthesis System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
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