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Tornier Tornier Perform Anatomic Glenoid System Keeled Glenoid - HSA Registration DE0509903

Access comprehensive regulatory information for Tornier Tornier Perform Anatomic Glenoid System Keeled Glenoid in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0509903 and owned by Tornier SAS. The device was registered on October 11, 2024.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS C
DE0509903
Tornier Tornier Perform Anatomic Glenoid System Keeled Glenoid
HSA Registration Number: DE0509903
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Product 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: โ€ข Degenerative pathologies: primary arthrosis, secondary arthrosis such as post-traumatic arthrosis or primary and secondary necrosis of the humeral head. โ€ข Inflammatory disease such as rheumatoid arthritis. โ€ข 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.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Orthopaedics
Registration Information
Registration Number
DE0509903
Registration Date
October 11, 2024
Change Notification Approval Date
December 20, 2024
Retention Due Date
October 10, 2025
Product Owner
Short Name
Tornier SAS
Address
161 Rue Lavoisier, 38330 Montbonnot-Saint-Martin, FRANCE
Registrant
Address
1 GEORGE STREET, ONE GEORGE STREET, #20-1/2/3, SINGAPORE 049145
Importer
Address
1 GEORGE STREET, ONE GEORGE STREET, #20-1/2/3, SINGAPORE 049145
Model Information
Model Name(s)
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 0ยฐ PIN GUIDE 5ยฐ PIN GUIDE 10ยฐ 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(s)
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