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Wright Medical INFINITY Total Ankle System - HSA Registration DE0503986

Access comprehensive regulatory information for Wright Medical INFINITY Total Ankle 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 DE0503986 and owned by Wright Medical Technology Inc.. The device was registered on January 03, 2020.

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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HSA Official Data
CLASS C
DE0503986
Wright Medical INFINITY Total Ankle System
HSA Registration Number: DE0503986
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Product Description

The INFINITY® Total Ankle System is intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint. The INFINITY® Total Ankle System is indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Orthopaedics
Registration Information
Registration Number
DE0503986
Registration Date
January 03, 2020
Change Notification Approval Date
December 12, 2024
Retention Due Date
January 02, 2026
Product Owner
Short Name
Wright Medical Technology Inc.
Address
1023 Cherry Road, Memphis, TN 38117, 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)
INBONE STEINMANN PIN NARROW SAW BLADE WIDE SAW BLADE INBONE TALAR REAMER INBONE TALAR REAMER INBONE™ TALAR DOME SZ 2 SULCUS INBONE™ TALAR DOME SZ 3 SULCUS INBONE™ TALAR DOME SZ 4 SULCUS INBONE™ TALAR DOME SZ 5 SULCUS INFINITY Tibial Corner Drill INFINITY TALAR DOME TRIAL INFINITY TALAR DOME TRIAL INFINITY TALAR DOME TRIAL INFINITY TALAR DOME TRIAL INFINITY TALAR DOME TRIAL INFINITY TALAR DOME TRIAL INFINITY TALAR REAMER INFINITY TALAR REAMER INFINITY PIN INFINITY TEMP FIX PIN TALAR GUIDE INFINITY TEMP FIX PIN TALAR RESECT GUIDE INFINITY TIBIAL TRAY TRIAL INFINITY TIBIAL TRAY TRIAL INFINITY TIBIAL TRAY TRIAL INFINITY TIBIAL TRAY TRIAL INFINITY POLY INSERT TRIAL INFINITY POLY INSERT TRIAL INFINITY POLY INSERT TRIAL INFINITY POLY INSERT TRIAL INFINITY POLY INSERT TRIAL INFINITY POLY INSERT TRIAL INFINITY POLY INSERT TRIAL INFINITY POLY INSERT TRIAL INFINITY POLY INSERT TRIAL INFINITY POLY INSERT TRIAL INFINITY POLY INSERT TRIAL INFINITY POLY INSERT TRIAL INFINITY POLY INSERT TRIAL INFINITY POLY INSERT TRIAL INFINITY POLY INSERT TRIAL INFINITY POLY INSERT TRIAL INFINITY POLY INSERT TRIAL INFINITY POLY INSERT TRIAL INFINITY POLY INSERT TRIAL INFINITY POLY INSERT TRIAL INFINITY POLY INSERT TRIAL INFINITY POLY INSERT TRIAL INFINITY POLY INSERT TRIAL INFINITY POLY INSERT TRIAL INFINITY POLY INSERT TRIAL INFINITY POLY INSERT TRIAL INFINITY POLY INSERT TRIAL INFINITY POLY INSERT TRIAL INFINITY POLY INSERT TRIAL INFINITY POLY INSERT TRIAL INFINITY POLY INSERT TRIAL INFINITY POLY INSERT TRIAL INFINITY™ TIBIAL TRAY LEFT SZ2 INFINITY™ TIBIAL TRAY LEFT SZ3 INFINITY™ TIBIAL TRAY LEFT SZ5 INFINITY™ TIBIAL TRAY RGHT SZ1 INFINITY™ TIBIAL TRAY RGHT SZ3 INFINITY™ TIBIAL TRAY RGHT SZ4 INFINITY™ TIBIAL TRAY RGHT SZ5 INFINITY™ TALAR DOME SZ 1 TOTAL ANKLE SYSTEM INFINITY™ TALAR DOME SZ 2 TOTAL ANKLE SYSTEM INFINITY™ TALAR DOME SZ 3 TOTAL ANKLE SYSTEM INFINITY™ TALAR DOME SZ 4 TOTAL ANKLE SYSTEM INFINITY™ TALAR DOME SZ 5 TOTAL ANKLE SYSTEM INFINITY™ TALAR DOME SZ 6 TOTAL ANKLE SYSTEM INFINITY™ POLY INSERT SZ 1 / 1+ 6MM INFINITY™ POLY INSERT SZ 1 / 1+ 8MM INFINITY™ POLY INSERT SZ 1 / 1+ 10MM INFINITY™ POLY INSERT SZ 1 / 1+ 12MM INFINITY™ POLY INSERT SZ 2 6MM INFINITY™ POLY INSERT SZ 2 8MM INFINITY™ TIBIAL TRAY SIZE 1 TOTAL ANKLE SYSTEM INFINITY™ TIBIAL TRAY SIZE 2 TOTAL ANKLE SYSTEM INFINITY™ TIBIAL TRAY SIZE 3 TOTAL ANKLE SYSTEM INFINITY™ TIBIAL TRAY SIZE 4 TOTAL ANKLE SYSTEM INFINITY™ TIBIAL TRAY SIZE 5 TOTAL ANKLE SYSTEM INFINITY™ TIBIAL TRAY SIZE 6 TOTAL ANKLE SYSTEM INFINITY™ TIBIAL TRAY SZ 3 LNG TOTAL ANKLE SYSTEM INFINITY™ TIBIAL TRAY SZ 4 LNG TOTAL ANKLE SYSTEM INFINITY™ TIBIAL TRAY SZ 5 LNG TOTAL ANKLE SYSTEM INFINITY™ TIBIAL TRAY SZ 6 LNG TOTAL ANKLE SYSTEM INFINITY™ POLY INSERT SZ 1 / 1+ 6MM TOTAL ANKLE SYSTEM INFINITY™ POLY INSERT SZ 1 / 1+ 8MM TOTAL ANKLE SYSTEM INFINITY™ POLY INSERT SZ 1 / 1+ 10MM TOTAL ANKLE SYSTEM INFINITY™ POLY INSERT SZ 1 / 1+ 12MM TOTAL ANKLE SYSTEM INFINITY™ POLY INSERT SZ 2 6MM TOTAL ANKLE SYSTEM INFINITY™ POLY INSERT SZ 2 8MM TOTAL ANKLE SYSTEM INFINITY™ POLY INSERT SZ 2 10MM TOTAL ANKLE SYSTEM INFINITY™ POLY INSERT SZ 2 12MM TOTAL ANKLE SYSTEM INFINITY™ POLY INSERT SZ 2+ 6MM TOTAL ANKLE SYSTEM INFINITY™ POLY INSERT SZ 2+ 8MM TOTAL ANKLE SYSTEM INFINITY™ POLY INSERT SZ 2+ 10MM TOTAL ANKLE SYSTEM INFINITY™ POLY INSERT SZ 2+ 12MM TOTAL ANKLE SYSTEM INFINITY™ POLY INSERT SZ 3 6MM TOTAL ANKLE SYSTEM INFINITY™ POLY INSERT SZ 3 8MM TOTAL ANKLE SYSTEM INFINITY™ POLY INSERT SZ 3 10MM TOTAL ANKLE SYSTEM INFINITY™ POLY INSERT SZ 3 12MM TOTAL ANKLE SYSTEM INFINITY™ POLY INSERT SZ 3+ 7MM TOTAL ANKLE SYSTEM INFINITY™ POLY INSERT SZ 3+ 9MM TOTAL ANKLE SYSTEM INFINITY™ POLY INSERT SZ 3+ 11MM TOTAL ANKLE SYSTEM INFINITY™ POLY INSERT SZ 3+ 13MM TOTAL ANKLE SYSTEM INFINITY™ POLY INSERT SZ 4 6MM TOTAL ANKLE SYSTEM INFINITY™ POLY INSERT SZ 4 8MM TOTAL ANKLE SYSTEM INFINITY™ POLY INSERT SZ 4 10MM TOTAL ANKLE SYSTEM INFINITY™ POLY INSERT SZ 4 12MM TOTAL ANKLE SYSTEM INFINITY™ POLY INSERT SZ 4+ 7MM TOTAL ANKLE SYSTEM INFINITY™ POLY INSERT SZ 4+ 9MM TOTAL ANKLE SYSTEM INFINITY™ POLY INSERT SZ 4+ 11MM TOTAL ANKLE SYSTEM INFINITY™ POLY INSERT SZ 4+ 13MM TOTAL ANKLE SYSTEM INFINITY™ POLY INSERT SZ 5 6MM TOTAL ANKLE SYSTEM INFINITY™ POLY INSERT SZ 5 8MM TOTAL ANKLE SYSTEM INFINITY™ POLY INSERT SZ 5 10MM TOTAL ANKLE SYSTEM INFINITY™ POLY INSERT SZ 5 12MM TOTAL ANKLE SYSTEM CHARLOTTE 7.0 MUC HANDLE QUICK CONNECT K-WIRE INBONE TALAR PEG DRILL INBONE SCREW, BONE REMOVER INBONE TALAR DOME SULCUS, TRIAL INBONE TALAR DOME SULCUS, TRIAL INBONE TALAR DOME SULCUS, TRIAL INBONE TALAR DOME SULCUS, TRIAL
Model Identifier(s)
200072 200138107S 200138108S 200432010 200432014 220220902 220220903 220220904 220220905 33600048 33600071 33600072 33600073 33600074 33600075 33600076 33600123 33600126 33610001 33610002 33610003 33620062 33620063 33620064 33620065 33621106 33621108 33621110 33621112 33622206 33622208 33622210 33622212 33623206 33623208 33623210 33623212 33623306 33623308 33623310 33623312 33624307 33624309 33624311 33624313 33624406 33624408 33624410 33624412 33625407 33625409 33625411 33625413 33625506 33625508 33625510 33625512 33630002 33630003 33630005 33630011 33630013 33630014 33630015 33630021 33630022 33630023 33630024 33630025 33630026 33631106 33631108 33631110 33631112 33632206 33632208 33650001 33650002 33650003 33650004 33650005 33650006 33650013 33650014 33650015 33650016 33651106 33651108 33651110 33651112 33652206 33652208 33652210 33652212 33653206 33653208 33653210 33653212 33653306 33653308 33653310 33653312 33654307 33654309 33654311 33654313 33654406 33654408 33654410 33654412 33655407 33655409 33655411 33655413 33655506 33655508 33655510 33655512 44180025 500036 IB200020 IB200051 IB220902 IB220903 IB220904 IB220905