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Synthes KINCISE™ Surgical Automated System - HSA Registration DE0510607

Access comprehensive regulatory information for Synthes KINCISE™ Surgical Automated System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0510607 and owned by Synthes GmbH. The device was registered on April 19, 2025.

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 B
DE0510607
Synthes KINCISE™ Surgical Automated System
HSA Registration Number: DE0510607
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Product Description

Intended to impact bone for bone preparation, implant assembly and extraction, and implant positioning during orthopaedic surgeries.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Orthopaedics
Registration Information
Registration Number
DE0510607
Registration Date
April 19, 2025
Retention Due Date
April 18, 2026
Product Owner
Short Name
Synthes GmbH
Address
Eimattstrasse 3, 4436 Oberdorf, SWITZERLAND
Registrant
Address
2 SCIENCE PARK DRIVE, ASCENT, #07-13, SINGAPORE 118222
Importer
Address
2 SCIENCE PARK DRIVE, ASCENT, #07-13, SINGAPORE 118222
Model Information
Model Name(s)
KINCISE™ System Automated Surgical Handpiece V2 KINCISE™ System Primary Hip PINNACLE™ Straight Shell/Liner Impactor - Long KINCISE™ System Primary Hip PINNACLE™ Offset Shell/Liner Impactor KINCISE™ System Primary Hip PINNACLE™ Inclination Guide KINCISE™ System Primary Hip PINNACLE™ Version Guide KINCISE™ System Primary Hip PINNACLE™ Straight Shell/Liner Impactor - Short KINCISE™ System Primary Hip Femoral Broach Adapter - Curved KINCISE™ System Primary Hip Femoral Broach Adapter - Straight KINCISE™ System Primary Hip CORAIL™ TRI-LOCK™ Stem Impactor - Offset KINCISE™ System Primary Hip ACTIS™ Stem Impactor - Offset KINCISE™ System Primary Hip CORAIL™ TRI-LOCK™ SUMMIT™ Stem Impactor- Straight KINCISE™ System Primary Hip ACTIS™ Stem Impactor - Straight KINCISE™ System Primary Hip Femoral Head Impactor - Shaft EMPHASYS™ KINCISE™ System Straight Shell/Liner Impactor - Long EMPHASYS™ KINCISE™ System Offset Shell/Liner Impactor EMPHASYS™ KINCISE™ System Straight Shell/Liner Impactor - Short EMPHASYS™ KINCISE™ System Stem Impactor - Straight EMPHASYS™ KINCISE™ System Stem Impactor - Offset KINCISE™ System Primary Hip Threaded Femoral STEM Extractor - M6 X 1mm KINCISE™ System ATTUNE™ Revision Broach Adapter
Model Identifier(s)
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