Thoraco-lumbo-sacral osteosynthesis unit 510K-163363

posterioradult

The SurgTech Thoraco-Lumbo-Sacral (TLS) Posterior Fixation System consists of longitudinal members (rods), anchors (hooks and screws), interconnections (cross connector) and fasteners in a variety of sizes to accommodate differing anatomic requirements. The SurgTech Thoraco-Lumbo-Sacral (TLS) Posterior Fixation System is intended to provide pedicle and non-pedicle immobilization and stabilization of the posterior non-cervical spine (T1-S2 / Ilium) in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities. Features The SurgTech Thoraco-Lumbo-Sacral (TLS) Posterior Fixation System is available in a wide range of sizes, consisting of Polyaxial Pedicle Screws, Monoaxial Pedicle Screws, Polyaxial Reduction Pedicle Screws, Monoaxial Reduction Pedicle Screws, Straight, Hex Ends Rods, Straight, Bevel Ends Rods, Curved, Bevel Ends Rods, Cross-connector, Hooks (Pedicle, Standard Laminar, Narrow Blade, Wide Blade, Reduced Distance, Extended Body, Angled), Set Screw. Proposed Trade Name: SurgTech Thoraco-lumbo-sacral (TLS) Posterior Fixation System Common Name: Posterior Pedicle Screw and Hook System Regulatory Class: Class II Regulatory Name and Number: Thoraco-lumbo-sacral pedicle screw system, 21 CFR 888.3070, NKB Product Code: Spinal Interlaminal Fixation Orthosis, 21 CFR 888.3050, KWP Materials: SurgTech TLS System is manufactured from titanium alloys (Ti-6Al-4V ELI per ASTM F136 and Ti-6Al-7Nb per ASTM F1295).