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Tornier Tornier Perform Reversed Glenoid and Perform Reversed Augmented Glenoid System - HSA Registration DE0509083

Access comprehensive regulatory information for Tornier Tornier Perform Reversed Glenoid and Perform Reversed Augmented Glenoid System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0509083 and owned by Tornier, Inc. The device was registered on March 20, 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
DE0509083
Tornier Tornier Perform Reversed Glenoid and Perform Reversed Augmented Glenoid System
HSA Registration Number: DE0509083
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Product Description

The Tornier Perform Reversed and Tornier Perform Reversed Augmented glenoids are intended for replacement of the shoulder joint to reduce pain and improve shoulder mobility in comparison with preoperative status. The Tornier Perform Reversed and Tornier Perform Reversed Augmented Glenoid are indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and with massive and non-repairable rotator cuff-tear with pain disabled by: Rheumatoid arthritis; Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis); Correction of functional deformity; Fractures of the humeral head; Traumatic arthritis; Revision of the devices if sufficient bone stock remains

Device Classification
Device Class
CLASS C
Medical Speciality Area
Orthopaedics
Registration Information
Registration Number
DE0509083
Registration Date
March 20, 2024
Change Notification Approval Date
October 04, 2024
Retention Due Date
March 19, 2026
Product Owner
Short Name
Tornier, Inc
Address
10801 Nesbitt Avenue South, 55437, Bloomington, Minnesota, UNITED STATES
Registrant
Address
1 GEORGE STREET, ONE GEORGE STREET, #20-1/2/3, SINGAPORE 049145
Importer
Address
47 JALAN BUROH, #09-01, SINGAPORE 619491 1 GEORGE STREET, ONE GEORGE STREET, #20-1/2/3, SINGAPORE 049145
Model Information
Model Name(s)
GUIDEWIRE 2.5MM X 220MM PRESS-FIT SHORT POST, LENGTH: 7MM PRESS-FIT LONG POST, LENGTH: 15MM STANDARD GLENOSPHERE, 36MM STANDARD GLENOSPHERE, 39MM STANDARD GLENOSPHERE, 42MM LATERALIZED GLENOSPHERE, OFFSET: +3MM, 33MM LATERALIZED GLENOSPHERE, OFFSET: +3MM, 36MM LATERALIZED GLENOSPHERE, OFFSET: +3MM, 39MM LATERALIZED GLENOSPHERE, OFFSET: +3MM, 42MM ECCENTRIC GLENOSPHERE, OFFSET: +2MM, 36MM ECCENTRIC GLENOSPHERE, OFFSET: +2MM, 39MM ECCENTRIC GLENOSPHERE, OFFSET: +2MM, 42MM CANNULATED TI STANDARD GLENOSPHERE, 36MM CANNULATED TI STANDARD GLENOSPHERE, 39MM CANNULATED TI STANDARD GLENOSPHERE, 42MM CANNULATED TI LATERALIZED GLENOSPHERE, OFFSET: +3MM, 33MM CANNULATED TI LATERALIZED GLENOSPHERE, OFFSET: +3MM, 36MM CANNULATED TI LATERALIZED GLENOSPHERE, OFFSET: +3MM, 39MM CANNULATED TI LATERALIZED GLENOSPHERE, OFFSET: +3MM, 42MM CANNULATED COCR STANDARD GLENOSPHERE, 36MM CANNULATED COCR STANDARD GLENOSPHERE, 39MM CANNULATED COCR STANDARD GLENOSPHERE, 42MM CANNULATED COCR LATERALIZED GLENOSPHERE, OFFSET: +3MM, 33MM CANNULATED COCR LATERALIZED GLENOSPHERE, OFFSET: +3MM, 36MM CANNULATED COCR LATERALIZED GLENOSPHERE, OFFSET: +3MM, 39MM CANNULATED COCR LATERALIZED GLENOSPHERE, OFFSET: +3MM, 42MM CANNULATED TI ECCENTRIC GLENOSPHERE OFFSET: +2MM INFERIOR CANNULATED TI ECCENTRIC GLENOSPHERE OFFSET: +3MM INFERIOR CANNULATED TI ECCENTRIC GLENOSPHERE OFFSET: +4MM INFERIOR CANNULATED COCR ECCENTRIC GLENOSPHERE OFFSET: +2MM INFERIOR CANNULATED COCR ECCENTRIC GLENOSPHERE OFFSET: +3MM INFERIOR CANNULATED COCR ECCENTRIC GLENOSPHERE OFFSET: +4MM INFERIOR CENTRAL SCREW, DIAMETER: 6.5MM, LENGTH: 25MM CENTRAL SCREW, DIAMETER: 6.5MM, LENGTH: 30MM CENTRAL SCREW, DIAMETER: 6.5MM, LENGTH: 35MM CENTRAL SCREW, DIAMETER: 6.5MM, LENGTH: 40MM CENTRAL SCREW, DIAMETER: 6.5MM, LENGTH: 45MM CENTRAL SCREW, DIAMETER: 6.5MM, LENGTH: 50MM CENTRAL SCREW, DIAMETER: 9.5MM, LENGTH: 25MM CENTRAL SCREW, DIAMETER: 9.5MM, LENGTH: 30MM CENTRAL SCREW, DIAMETER: 9.5MM, LENGTH: 35MM CENTRAL SCREW, DIAMETER: 9.5MM, LENGTH: 40MM CENTRAL SCREW, DIAMETER: 9.5MM, LENGTH: 45MM CENTRAL SCREW, DIAMETER: 9.5MM, LENGTH: 50MM PERIPHERAL SCREW, DIAMETER: 5.0MM, LENGTH: 14MM PERIPHERAL SCREW, DIAMETER: 5.0MM, LENGTH: 18MM PERIPHERAL SCREW, DIAMETER: 5.0MM, LENGTH: 22MM PERIPHERAL SCREW, DIAMETER: 5.0MM, LENGTH: 26MM PERIPHERAL SCREW, DIAMETER: 5.0MM, LENGTH: 30MM PERIPHERAL SCREW, DIAMETER: 5.0MM, LENGTH: 34MM PERIPHERAL SCREW, DIAMETER: 5.0MM, LENGTH: 36MM PERIPHERAL SCREW, DIAMETER: 5.0MM, LENGTH: 42MM PERIPHERAL SCREW, DIAMETER: 5.0MM, LENGTH: 46MM PERIPHERAL SCREW, DIAMETER: 5.0MM, LENGTH: 50MM PERIPHERAL SCREW, DIAMETER: 5.0MM, LENGTH: 54MM STANDARD BASEPLATE, 25MM STANDARD BASEPLATE, 29MM LATERALIZED BASEPLATE, OFFSET: +3MM, 25MM LATERALIZED BASEPLATE, OFFSET: +6MM, 25MM HALF WEDGE AUGMENT BASEPLATE, 35°, 25MM FULL WEDGE AUGMENT BASEPLATE, 15°, 25MM LATERALIZED BASEPLATE, OFFSET: +3MM, 29MM LATERALIZED BASEPLATE, OFFSET: +6MM, 29MM HALF WEDGE AUGMENT BASEPLATE, 35°, 29MM FULL WEDGE AUGMENT BASEPLATE, 15°, 29MM CENTRAL SCREW, DIAMETER: 6.5MM, LENGTH: 25MM CENTRAL SCREW, DIAMETER: 6.5MM, LENGTH: 30MM CENTRAL SCREW, DIAMETER: 6.5MM, LENGTH: 35MM CENTRAL SCREW, DIAMETER: 6.5MM, LENGTH: 40MM CENTRAL SCREW, DIAMETER: 6.5MM, LENGTH: 45MM CENTRAL SCREW, DIAMETER: 6.5MM, LENGTH: 50MM CENTRAL SCREW, DIAMETER: 9.5MM, LENGTH: 25MM CENTRAL SCREW, DIAMETER: 9.5MM, LENGTH: 30MM CENTRAL SCREW, DIAMETER: 9.5MM, LENGTH: 35MM CENTRAL SCREW, DIAMETER: 9.5MM, LENGTH: 40MM CENTRAL SCREW, DIAMETER: 9.5MM, LENGTH: 45MM CENTRAL SCREW, DIAMETER: 9.5MM, LENGTH: 50MM PERIPHERAL SCREW, DIAMETER: 5.0MM, LENGTH: 14MM, STERILE PERIPHERAL SCREW, DIAMETER: 5.0MM, LENGTH: 18MM, STERILE PERIPHERAL SCREW, DIAMETER: 5.0MM, LENGTH: 22MM, STERILE PERIPHERAL SCREW, DIAMETER: 5.0MM, LENGTH: 26MM, STERILE PERIPHERAL SCREW, DIAMETER: 5.0MM, LENGTH: 30MM, STERILE PERIPHERAL SCREW, DIAMETER: 5.0MM, LENGTH: 34MM, STERILE PERIPHERAL SCREW, DIAMETER: 5.0MM, LENGTH: 36MM, STERILE PERIPHERAL SCREW, DIAMETER: 5.0MM, LENGTH: 42MM, STERILE PERIPHERAL SCREW, DIAMETER: 5.0MM, LENGTH: 46MM, STERILE PERIPHERAL SCREW, DIAMETER: 5.0MM, LENGTH: 50MM, STERILE PERIPHERAL SCREW, DIAMETER: 5.0MM, LENGTH: 54MM, STERILE CLEANING ROD FOR CANNULATED INSTRUMENTS GLENOID SPHERE/ANATOMIC HEAD IMPACTOR TIP OPEN-END WRENCH, 12MM CANNULATED REAMER DRIVER QUICK RELEASE HANDLE NEO-REAMER SLEEVE NEO-REAMER CANNULATED DRIVER SHAFT NEO-REAMER ANGLE INDICATOR NEO-REAMER DRIVE END NEO-REAMER HANDLE NEO-REAMER SLIDE NEO-REAMER WRENCH CHECKER HANDLE PROSTHESIS REDUCER SLIM CIRCULAR PIN GUIDE, 25MM CIRCULAR PIN GUIDE, 29MM ANATOMICAL PIN GUIDE, SIZE: SMALL ANATOMICAL PIN GUIDE, SIZE: MEDIUM STERILE NITINOL GUIDE WIRE CANNULATED GLENOSPHERE INSERTER ANATOMICAL PIN GUIDE, SIZE: LARGE ANATOMICAL PIN GUIDE, SIZE: EXTRA LARGE PIN GUIDE ANGLE, 0° PIN GUIDE ANGLE, 10° HALF MOON BASEPLATE REAMER, 24MM HALF MOON BASEPLATE REAMER, 29MM CENTRAL SCREW DRILL, 6.5MM CENTRAL SCREW DRILL, 9.5MM BASEPLATE POST DRILL, 10MM CENTRAL SCREW DRILL GUIDE, 6.5MM CENTRAL SCREW DRILL GUIDE, 9.5MM CENTRAL SCREW DEPTH GAUGE PIN GUIDE HANDLE, OFFSET BASEPLATE INSERTER HANDLE PERIPHERAL REAMER, 33-36MM PERIPHERAL REAMER, 39-42MM CENTRAL SCREW TAP, 6.5MM CENTRAL SCREW TAP, 9.5MM BASEPLATE INSERTER SCREWDRIVER, T20 PERIPHERAL SCREW DRILL GUIDE PERIPHERAL SCREW DEPTH GAUGE PERIPHERAL SCREW DRILL BIT, 3.2MM, STERILE PERIPHERAL AND SPHERE SCREWDRIVER BIT, T20 RATCHETING SCREWDRIVER HANDLE FULL WEDGE PILOT DRILL, 8MM GLENOSPHERE EXTRACTOR STANDARD GLENOSPHERE TRIAL, 36MM STANDARD GLENOSPHERE TRIAL, 39MM STANDARD GLENOSPHERE TRIAL, 42MM LATERALIZED GLENOSPHERE TRIAL, OFFSET: +3MM, 33MM LATERALIZED GLENOSPHERE TRIAL, OFFSET: +3MM, 36MM LATERALIZED GLENOSPHERE TRIAL, OFFSET: +3MM, 39MM LATERALIZED GLENOSPHERE TRIAL, OFFSET: +3MM, 42MM ECCENTRIC GLENOSPHERE TRIAL, OFFSET: +2MM, 36MM ECCENTRIC GLENOSPHERE TRIAL, OFFSET: +3MM, 39MM ECCENTRIC GLENOSPHERE TRIAL, OFFSET: +4MM, 42MM PERIPHERAL SCREW DRILL BIT, 3.2MM AUGMENT HALF WEDGE TRIAL, 25MM AUGMENT HALF WEDGE TRIAL, 29MM AUGMENT FULL WEDGE TRIAL, 25MM AUGMENT FULL WEDGE TRIAL, 29MM NON-CANNULATED BASEPLATE REAMER, 25MM NON-CANNULATED BASEPLATE REAMER, 29MM CENTRAL SCREW DRILL GUIDE, HALF WEDGE, 6.5MM CENTRAL SCREW DRILL GUIDE, HALF WEDGE, 9.5MM CENTRAL SCREW DRILL GUIDE, FULL WEDGE, 6.5MM CENTRAL SCREW DRILL GUIDE, FULL WEDGE, 9.5MM NON-CANNULATED BASEPLATE POST DRILL, 10MM NON-CANNULATED DRILL GUIDE, SIZE: 4MM, 25MM NON-CANNULATED DRILL GUIDE, SIZE: 4MM, 29MM PRESS-FIT POST DRILL, 8MM CENTRAL SCREW ASSEMBLY TOOL BASEPLATE REVISION TOOL BASEPLATE REAMER, 25MM BASEPLATE REAMER, 29MM NEO-REAMER DEPTH STOP, HALF WEDGE, 25MM NEO-REAMER DEPTH STOP, HALF WEDGE, 29MM NEO REAMER, FULL WEDGE, 25MM NEO REAMER, FULL WEDGE, 29MM NEO REAMER, HALF WEDGE, 25MM NEO REAMER, HALF WEDGE, 29MM PRESS-FIT POST DRILL, 7MM POST BASEPLATE POST HARD BONE DRILL BASEPLATE POST HARD BONE DRILL NON-CANNULATED
Model Identifier(s)
DWD017 DWJ001 DWJ002 DWJ012 DWJ013 DWJ014 DWJ021 DWJ022 DWJ023 DWJ024 DWJ032 DWJ033 DWJ034 DWJ1017201 DWJ1017202 DWJ1017203 DWJ1017204 DWJ1017205 DWJ1017206 DWJ1017207 DWJ1017301 DWJ1017302 DWJ1017303 DWJ1017304 DWJ1017305 DWJ1017306 DWJ1017307 DWJ1017601 DWJ1017602 DWJ1017603 DWJ1017701 DWJ1017702 DWJ1017703 DWJ125 DWJ130 DWJ135 DWJ140 DWJ145 DWJ150 DWJ225 DWJ230 DWJ235 DWJ240 DWJ245 DWJ250 DWJ314 DWJ318 DWJ322 DWJ326 DWJ330 DWJ334 DWJ338 DWJ342 DWJ346 DWJ350 DWJ354 DWJ401 DWJ411 DWJ502 DWJ503 DWJ504 DWJ505 DWJ512 DWJ513 DWJ514 DWJ515 DWJ525 DWJ530 DWJ535 DWJ540 DWJ545 DWJ550 DWJ625 DWJ630 DWJ635 DWJ640 DWJ645 DWJ650 DWJ714 DWJ718 DWJ722 DWJ726 DWJ730 DWJ734 DWJ738 DWJ742 DWJ746 DWJ750 DWJ754 MWB236 MWD425 MWD552 MWE151 MWE158 MWH601 MWH602 MWH603 MWH604 MWH605 MWH606 MWH607 MWH630 MWJ100 MWJ101 MWJ102 MWJ103 MWJ104 MWJ10461 MWJ10462 MWJ105 MWJ106 MWJ107 MWJ108 MWJ109 MWJ110 MWJ111 MWJ112 MWJ113 MWJ114 MWJ115 MWJ116 MWJ117 MWJ118 MWJ119 MWJ120 MWJ121 MWJ122 MWJ123 MWJ124 MWJ125 MWJ126 MWJ127 MWJ128 MWJ129 MWJ130 MWJ132 MWJ133 MWJ134 MWJ135 MWJ136 MWJ137 MWJ138 MWJ139 MWJ140 MWJ141 MWJ142 MWJ145 MWJ146 MWJ147 MWJ148 MWJ149 MWJ150 MWJ151 MWJ152 MWJ153 MWJ154 MWJ158 MWJ159 MWJ160 MWJ162 MWJ163 MWJ165 MWJ166 MWJ167 MWJ168 MWJ169 MWJ170 MWJ171 MWJ172 MWJ173 MWJ190 MWJ192 MWJ193