Singapore HSA registration DE0503686
ConMed SmartNail Implant System
Device classification
- Device Class
- CLASS D
- Medical Speciality Area
- Orthopaedics
Registration information
- Registration Number
- DE0503686
- Registration Date
- October 02, 2019
- Retention Due Date
- October 01, 2025
Product description
SmartNail(R) implants are intended for use in the fixation of fragments of fractured non-load bearing bones, osteotomies and arthrodeses, for example in the fixation of apical fragments, osteochondral fragments and cancellous/non-load bearing fragments in the presence of appropriate brace and / or immobilization.
Product Owner
- Short Name
- CONMED CORPORATION
- Address
- 525 FRENCH ROAD, UTICA, NEW YORK 13502, UNITED STATES OF AMERICA, UNITED STATES
Registrant
- Address
- 10 JALAN KILANG, BT Merah Enterprise Centre, #03-01, SINGAPORE 159410
Importer
- Address
- 10 JALAN KILANG, BT MERAH ENTERPRISE CENTRE, #03-01, SINGAPORE 159410 10 JALAN KILANG, BT MERAH ENTERPRISE CENTRE, #03-01, SINGAPORE 159410
Model information
- Model Name(s)
- SmartNail® ᵩ 1.5 x 16mm SmartNail® ᵩ 1.5 x 20mm SmartNail® ᵩ 1.5 x 25mm SmartNail® ᵩ 2.4 x 16mm SmartNail® ᵩ 2.4 x 25mm SmartNail® ᵩ 2.4 x 35mm SmartNail® ᵩ 2.4 x 45mm Handle Housing Wrench K-Wire Arthroscopic Piston L 190mm Arthroscopic Piston L 190mm Arthroscopic Tip L 121mm Arthroscopic Tip L 121mm Drill Bit, ᵩ 1.5mm, L 205mm Drill Bit, ᵩ 2.4mm, L 205mm Percutaneous Piston L205mm Percutaneous Tip L 93mm Percutaneous Tip, L 93mm Percutaneous Tip, L 205mm Drill Bit, ᵩ 1.5mm, L 209mm SmartNail® Sterilization Tray
- Model Identifier(s)
- 531516 531520 531525 532416 532425 532435 532445 AA1520-01 AA1520-04 AA1520-05 AA1520-07 AP1500 AP2400 AT1500 AT2400 DB1500 DB2400 PP2400 PT2400 SN1520-021 SN1520-031 SN1520-061 ST1007
About this record
Access comprehensive regulatory information for ConMed SmartNail Implant System in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0503686 and owned by CONMED CORPORATION. The device was registered on October 02, 2019.
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS D