Singapore HSA registration DE0510607
Synthes KINCISE™ Surgical Automated System
Singapore·CLASS B·Synthes GmbH·Registered April 19, 2025Device 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 description
Intended to impact bone for bone preparation, implant assembly and extraction, and implant positioning during orthopaedic surgeries.
Product Owner
- Name
- Synthes GmbH
- 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)
- 2000-00-001 200002002 200002003 200002005 200002006 200002012 200002101 200002102 200002202 200002203 200002212 200002213 200002301 200003001 200003002 200003012 200003201 200003202 200004012 200007008
About this record
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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