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HSA · registration DE0509903

Tornier Tornier Perform Anatomic Glenoid System Keeled Glenoid

SingaporeOrthopaedicsClass CTornier SAS
Official record identity
Registration number
DE0509903
Model name
SMALL FUKUDA; LARGE FUKUDA; CREGO; PIN, DIAMETER: 2.5MM, LENGTH: 200MM; PIN, DIAMETER: 2.5MM, LENGTH: 150MM; ALIGNMENT PIN - SMOOTH; KEELED GLENOID S30; KEELED GLENOID S35; KEELED GLENOID S40; KEELED GLENOID M30; KEELED GLENOID M35; KEELED GLENOID M40; KEELED GLENOID L40; KEELED GLENOID L50; KEELED GLENOID L60; KEELED GLENOID XL40; KEELED GLENOID XL50; KEELED GLENOID XL60; GLENOID TRIAL GRASPER; WIDE KOLBEL RETRACTOR; SMALL HOHMANN RETRACTOR; RESURFACING RETRACTOR WITHOUT TEETH; RESURFACING RETRACTOR WITH TEETH; CLEANING ROD; PIN DRIVER; NARROW LYON RETRACTOR; WIDE LYON RETRACTOR; FAVARD RETRACTOR; NARROW KOLBEL RETRACTOR; FORKED RETRACTOR; OPEN-END WRENCH 12MM; SIZER S30; SIZER S35; SIZER S40; SIZER M30; SIZER M35; SIZER M40; SIZER L40; SIZER L50; SIZER L60; SIZER XL40; SIZER XL50; SIZER XL60; RADIUS GAUGE S30 / M30; RADIUS GAUGE S35 / M35; RADIUS GAUGE S40 / M40; RADIUS GAUGE L40 / XL40; RADIUS GAUGE L50 / XL50; RADIUS GAUGE L60 / XL60; CENTRAL HOLE DRILL GUIDE DIAMETER: 6MM; DRILL GUIDE HANDLE; STABILIZATION PEG REMOVER; GLENOID IMPACTOR; STABILIZATION PEG DIAMETER: 5.4MM; KEELED PERIPHERAL DRILL GUIDE SMALL/MEDIUM; KEELED PERIPHERAL DRILL GUIDE LARGE/EXTRA LARGE; STABILIZATION PEG DIAMETER: 5MM; STABILIZATION PEG DIAMETER: 6MM; KEELED PUNCH SMALL/MEDIUM; KEELED PUNCH LARGE/EXTRA LARGE; WIDE BW RETRACTOR; NARROW BW RETRACTOR; SIZER CLAMP; PIN GUIDE 0°; PIN GUIDE 5°; PIN GUIDE 10°; GLENOID GRASPER; LARGE HOHMANN RETRACTOR; LAMINA SPREADER; SMOOTH TIP; GROOVE TIP; TAPERED TIP; RESURFACING TIP; ACROMIAL RETRACTOR; TRILLAT RETRACTOR / TEXAS TRILLAT; GELPI; ARTICULATED DRIVER; CANNULATED REAMER DRIVER; CANNULATED DRILL/REAMER DRIVER WITH TIP; CANNULATED CENTRAL HOLE DRILL BIT DIAMETER: 6MM, SMALL/MEDIUM; CENTRAL HOLE DRILL BIT DIAMETER: 6MM, SMALL/MEDIUM; CANNULATED CENTRAL HOLE DRILL BIT DIAMETER: 6MM, LARGE/ EXTRA LARGE; CENTRAL HOLE DRILL BIT DIAMETER: 6MM, LARGE/EXTRA LARGE; PIN 2.5MM X 200MM; QUICK RELEASE HANDLE; REAMER S30; REAMER S35; REAMER S40; REAMER M30; REAMER M35; REAMER M40; REAMER L40; REAMER L50; REAMER L60; REAMER XL40; REAMER XL50; REAMER XL60; T-HANDLE, SZH; PERIPHERAL DRILL BIT DIAMETER: 5MM; PERIPHERAL DRILL BIT DIAMETER: 5.4MM; PERIPHERAL DRILL BIT DIAMETER: 6MM; CRESCENT REAMER S30; CRESCENT REAMER S35; CRESCENT REAMER S40; CRESCENT REAMER M30; CRESCENT REAMER M35; CRESCENT REAMER M40; CRESCENT REAMER L40; CRESCENT REAMER L50; CRESCENT REAMER L60; CRESCENT REAMER XL40; CRESCENT REAMER XL50; CRESCENT REAMER XL60; KEELED GLENOID TRIAL S30; KEELED GLENOID TRIAL S35; KEELED GLENOID TRIAL S40; KEELED GLENOID TRIAL M30; KEELED GLENOID TRIAL M35; KEELED GLENOID TRIAL M40; KEELED GLENOID TRIAL L40; KEELED GLENOID TRIAL L50; KEELED GLENOID TRIAL L60; KEELED GLENOID TRIAL XL40; KEELED GLENOID TRIAL XL50; KEELED GLENOID TRIAL XL60
Model identifier
9000379; 9000380; 9000384; DWD063; DWD065; DWD168; DWE501; DWE502; DWE503; DWE511; DWE512; DWE513; DWE521; DWE522; DWE523; DWE531; DWE532; DWE533; MWA652; MWA681; MWA683; MWB070; MWB071; MWB236; MWB253; MWB352; MWB353; MWD001; MWD046; MWD160; MWD552; MWE011; MWE012; MWE013; MWE014; MWE015; MWE016; MWE017; MWE018; MWE019; MWE020; MWE021; MWE022; MWE031; MWE032; MWE033; MWE034; MWE035; MWE036; MWE040; MWE042; MWE044; MWE046; MWE083; MWE095; MWE096; MWE097; MWE098; MWE101; MWE102; MWE103; MWE104; MWE110; MWE111; MWE112; MWE113; MWE114; MWE120; MWE121; MWE122; MWE123; MWE124; MWE125; MWE126; MWE127; MWE128; MWE150; MWE151; MWE152; MWE153; MWE154; MWE155; MWE156; MWE157; MWE158; MWE160; MWE161; MWE162; MWE163; MWE164; MWE165; MWE166; MWE167; MWE168; MWE169; MWE170; MWE171; MWE180; MWE199; MWE200; MWE201; MWE260; MWE261; MWE262; MWE263; MWE264; MWE265; MWE266; MWE267; MWE268; MWE269; MWE270; MWE271; MWE501; MWE502; MWE503; MWE511; MWE512; MWE513; MWE521; MWE522; MWE523; MWE531; MWE532; MWE533
Registration date
October 11, 2024
Source update date
December 20, 2024
Classification
Risk class
Class C
Official value: CLASS C
Published category
Orthopaedics
Published parties
Product owner
Tornier SAS
Registrant / registration holder
STRYKER SINGAPORE PRIVATE LIMITED
Official description

Tornier Perform Anatomic Glenoid is intended for replacement of the shoulder joint to reduce pain and improve shoulder mobility in comparison with preoperative status. Prosthetic replacement with this device (Tornier Perform Anatomic Glenoid component) may be indicated to relieve severe pain or significant disability caused by: • Degenerative pathologies: primary arthrosis, secondary arthrosis such as post-traumatic arthrosis or primary and secondary necrosis of the humeral head. • Inflammatory disease such as rheumatoid arthritis. • Revision of anatomic hemiarthroplasty procedure to anatomic total shoulder arthroplasty when other treatments or devices have failed. The Tornier Perform Anatomic Glenoid is intended for cemented use only.

Additional source fields
Product owner address
161 Rue Lavoisier, 38330 Montbonnot-Saint-Martin, France
Registrant address
38 BEACH ROAD, #23-11, SOUTH BEACH TOWER, Singapore 189767
About this record

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.