HSA · registration DE0509719Arthrex Minimally Invasive Bunion Correction System Instrumentation
SingaporeOrthopaedicsClass BArthres, Inc.
Official record identity
- Registration number
- DE0509719
- Model name
- 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
- 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
- Registration date
- September 03, 2024
Classification
- Risk class
- Class B
Official value: CLASS B
Published parties
- Product owner
- Arthres, Inc.
- Registrant / registration holder
- ARTHREX SINGAPORE, PTE. LTD.
Official description
For site preparation, tissue manipulation and implant insertion during the fixation of bone fractures or bone reconstruction.
Additional source fields
- Product owner address
- 1370 Creekside Boulevard, Naples, Florida, 34108-1945, United States
- Registrant address
- Nucleous 21 Biopolis Rd., #03-08, Singapore 138567
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.