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Singapore HSA registration DE0509719

Arthrex Minimally Invasive Bunion Correction System Instrumentation

Singapore flagSingapore·CLASS B·Arthres, Inc.·Registered September 03, 2024
Device classification
Device Class
CLASS B
Medical Speciality Area
Orthopaedics
Registration information
Registration Number
DE0509719
Registration Date
September 03, 2024
Retention Due Date
September 02, 2025
Product description
For site preparation, tissue manipulation and implant insertion during the fixation of bone fractures or bone reconstruction.
Product Owner
Name
Arthres, Inc.
Short Name
Arthres, Inc.
Address
1370 Creekside Boulevard, Naples, Florida, 34108-1945, UNITED STATES
Registrant
Name
ARTHREX SINGAPORE, PTE. LTD.
Address
21 BIOPOLIS ROAD, NUCLEOS, #03-08, SINGAPORE 138567
Importer
Name
ARTHREX SINGAPORE PTE LTD
Address
Nucleous 21 Biopolis Rd., #03-08, SINGAPORE 138567
Model information
Model Name(s)
Drill Bit, Cannulated, 2 mm Driver Shaft, 1.5 mm Hex, Cannulated Guide Wire, Trocar Tip, with Laser Line, 0.86 mm Profile Drill, for Micro Compression FT Depth Device, Compression FT Screws Drill Bit, Cannulated, 2.2 mm Guidewire, 1.1 mm, for 3.5 & 4.0 mm Compression FT Guidewire, 1.4 mm, for 3.5 mm Beveled FT Guidewire, 1.4 mm, for 3.5 mm Beveled FT Guidewire, 1.6 mm, for 4.0 mm Beveled FT Guidewire, 1.6 mm, for 4.0 mm Beveled FT Capital Fragment Guidewire, MIS Bunion Guide, 1.6 mm Capital Fragment Guidewire, MIS Bunion Guide, 1.6 mm 2.9 mm Cannulated Drill, for 3.5 mm Beveled FT 2.9 mm Cannulated Drill, for 3.5 mm Beveled FT 2.9 mm Cannulated Drill, Short, for 3.5 mm Beveled FT 2.9 mm Cannulated Drill, Short, for 3.5 mm Beveled FT 3.6 mm Cannulated Drill, for 4.0 mm Beveled FT 3.6 mm Cannulated Drill, for 4.0 mm Beveled FT 3.6 mm Cannulated Drill, Short, for 4.0 mm Beveled FT 3.6 mm Cannulated Drill, Short, for 4.0 mm Beveled FT 3.8 mm Cannulated Drill, for 4.5 mm Beveled FT 3.8 mm Cannulated Drill, for 4.5 mm Beveled FT 3.8 mm Cannulated Drill, Short, for 4.5 mm Beveled FT 3.8 mm Cannulated Drill, Short, for 4.5 mm Beveled FT Profile Drill, 3.5 mm Beveled FT Profile Drill, Short, 3.5 mm Beveled FT Profile Drill, 4.0 mm Beveled FT Profile Drill, Short, 4.0 mm Beveled FT Profile Drill, 4.5 mm Beveled FT Profile Drill, Short, 4.5 mm Beveled FT
Model Identifier(s)
AR-8737-34 AR-8737-37 AR-8737-39 AR-8737-46 AR-8737-51 AR-8737-58 AR-8741-13 AR-8741-14 AR-8741-14S AR-8741-15 AR-8741-15S AR-8741-16 AR-8741-16S AR-8741-25 AR-8741-25-RU AR-8741-25S AR-8741-25S-RU AR-8741-32 AR-8741-32-RU AR-8741-32S AR-8741-32S-RU AR-8741-34 AR-8741-34-RU AR-8741-34S AR-8741-34S-RU AR-8741-36 AR-8741-36S AR-8741-37 AR-8741-37S AR-8741-38 AR-8741-38S
About this record

Access comprehensive regulatory information for Arthrex Minimally Invasive Bunion Correction System Instrumentation in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0509719 and owned by Arthres, Inc.. The device was registered on September 03, 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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