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ConMed SmartNail Implant System - HSA Registration DE0503686

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.

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CLASS D
DE0503686
ConMed SmartNail Implant System
HSA Registration Number: DE0503686
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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.

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 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