HSA · registration DE0509743RELIGN Tricera System
- Registration number
- DE0509743
- Model name
- RF CONTROLLER; Veriflow™; Dynablator™; 3-in-1 Shaver™ 4.2 mm; Standard Shaver 3.4 mm; 3-in-1 Shaver™ 5.0 mm; Exoflow™; Standard Burr 5.0 mm; Tricera™ Handpiece, Autoclavable; Curved Standard Shaver 3.4mm
- Model identifier
- R-10001; R-10003; R-10005; R-10008; R-10012; R-10014; R-10017; R-10021; R-10023; R-10024
- Registration date
- September 06, 2024
- Risk class
- Class C
- Product owner
- RELIGN Corporation
- Registrant / registration holder
- ZIMMER PTE. LTD.
The Tricera System is indicated for use in orthopedic and arthroscopic procedures. The Fluid Management System of the Tricera Arthroscopic System provides fluid distension and irrigation of the knee, shoulder, ankle, elbow, wrist and hip, and fluid suction during diagnostic and operative arthroscopic procedures. The Shaver Blade/RF Probe of the Tricera Arthroscopic System provides abrasion, resection, debridement, and removal of bone through its shaver blade; removal, ablation, and coagulation of soft tissue; as well as hemostasis of blood vessels through its shaver blade and probe. Examples of uses of the product include resection of torn knee cartilage, subacromial decompression, and resection of synovial tissue in other joints.
- Product owner address
- 655 Campbell Technology Parkway, Su, Campbell, California 95008, United States
- Registrant address
- 401 COMMONWEALTH DRIVE, #06-03, HAW PAR TECHNO CENTRE, Singapore 149598
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.