Device Dossier

Perla - Bone-screw internal spinal fixation system, sterile

Device Dossier for Perla - Bone-screw internal spinal fixation system, sterile (Bone-screw internal spinal fixation system, sterile, Class IIb, sponsor…

Intended purpose

Pedicle screw instrumentation system that consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion.

TGA Public Summary