Stryker CORE 2 System - HSA Registration DE0502148
Access comprehensive regulatory information for Stryker CORE 2 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 DE0502148 and owned by Stryker Instruments. The device was registered on September 12, 2018.
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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HSA Official Data
CLASS B
DE0502148
Stryker CORE 2 System
HSA Registration Number: DE0502148
Product Description
The Stryker Consolidated Operating Room Equipment (CORE) 2 Console is intended for use in the cutting, drilling, reaming, decorticating, shaping, and smoothing of bone, bone cement and teeth in a variety of surgical procedures, including but not limited to orthopedic, dental, ENT (Ear, Nose, Throat), neuro, spine, and endoscopic applications. The console is also usable in the placement or cutting of screws, metal, wires, pins, and other fixation devices.
Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0502148
Registration Date
September 12, 2018
Change Notification Approval Date
February 27, 2023
Retention Due Date
September 11, 2025
Product Owner
Short Name
Stryker Instruments
Address
1941 Stryker Way, Portage MI 49002, UNITED STATES
Registrant
Address
1 GEORGE STREET, ONE GEORGE STREET, #20-1/2/3, SINGAPORE 049145
Importer
Address
47 JALAN BUROH, #09-01, SINGAPORE 619491
11 LORONG 3 TOA PAYOH, JACKSON SQUARE, #01-13, SINGAPORE 319579
1 GEORGE STREET, ONE GEORGE STREET, #20-1/2/3, SINGAPORE 049145
Model Information
Model Name(s)
TPS Cord
TPS Unidirectional Footswitch
TPS Footswitch IPx7
CORE, Maestro Oil Cartridge
CORE, Maestro Diffuser
CORE 2 Console
CORE, Maestro Non-exhausting Footpedal
CORE, Maestro Large Non-exhausting Footpedal
CORE, Maestro Footpedal
CORE, Maestro Universal Footpedal
Core Accessories Storage Cart
HD 9cm Irrigation Clip
Elite 7cm Irrigation Clip
Elite 12-20cm Irrigation Clip
1.1mm Straight Router
Pi Drive Motor
1.7mm Match Head
1.7mm Diamond Match Head
2.2mm Match Head
2.2mm Diamond Match Head
Hd 9cm Straight Attachment
Hd 9cm Angled Attachment
Hd 14cm Straight Attachment
Hd 14cm Angled Attachment
Elite 7cm Straight Attachment
Elite 7cm Angled Attachment
Elite 12cm Straight Attachment
Elite 12cm Angled Attachment
Elite 14cm Straight Attachment
Elite 14cm Angled Attachment
Elite 14cm Hooded Attachment
Elite 17cm Straight Attachment
Elite 17cm Angled Attachment
Elite 20cm Straight Attachment
Elite 20cm Angled Attachment
MIS Hub
MIS 13cm Straight Attachment
MIS 13cm Angled Attachment
MIS 13cm Curved Attachment
MIS 16cm Straight Attachment
MIS 16cm Angled Attachment
MIS 16cm Curved Attachment
Pi Drive 2 Motor
Maestro Air Motor
Maestro Air Motor with Handswitch
Pi Drive Plus Motor
Motor Extender
Pi Drive Plus 2 Motor
Footed Attachment 12mm
Rotating Footed Attachment12mm
1.5mm Tapered Router
1.5mm Spiral Router
Footed Attachment 16mm
Rotating Footed Attachment16mm
2.3mm Tapered Router
2.3mm Spiral Router
Footed Attachment 25mm
Rotating Footed Attachment25mm
3.0mm Tapered Router
3.0mm Spiral Router
Non Footed Attachment 8cm
Non Footed Attachment 9cm
2.0mm Round
3.0mm Round
4.0mm Round
5.0mm Round
6.0mm Round
2.0mm Round, Extended
iBur™ 3.0mm Precision Round, Distal Bend
iBur™ 4.0mm Precision Round, Distal Bend
iBur™ 2.0mm Diamond Round, Distal Bend
iBur™ 3.0mm Diamond Round, Distal Bend
iBur™ 4.0mm Diamond Round, Distal Bend
iBur™ 3.0mm Coarse Diamond Round, Distal Bend
iBur™ 4.0mm Coarse Diamond Round, Distal Bend
iBur™ 5.0mm Coarse Diamond Round, Distal Bend
iBur™ 3.0mm Diamond Match Head, Distal Bend
iBur™ 3.0mm Precision Match Head, Distal Bend
iBur™ 3.0mm Precision Round, Proximal Bend
iBur™ 4.0mm Precision Round, Proximal Bend
iBur™ 2.5mm Diamond Match Head, Proximal Bend
iBur™ 3.0mm Diamond Match Head, Proximal Bend
iBur™ 2.5mm Precision Match Head, Proximal Bend
iBur™ 3.0mm Precision Match Head, Proximal Bend
2.0mm Precision Round, 13cm
3.0mm Precision Round, 13cm
4.0mm Precision Round, 13cm
5.0mm Precision Round, 13cm
2.0mm Round, 13cm
3.0mm Round, 13cm
4.0mm Round, 13cm
2.0mmCrse Dmnd Round, 13cm
3.0mm Crse Dmnd Round, 13cm
4.0mm Crse Dmnd Round, 13cm
4.0mm X-Crse Dmnd Round, 13cm
5.0mm X-Crse Dmnd Round, 13cm
1.5mm Mtch Hd , 13cm
1.5mm Dmnd Mtch Hd, 13cm
2.0mm Mtch Hd , 13cm
2.0mm Dmnd Mtch Hd, 13cm
2.5mm Mtch Hd , 13cm
2.5mm Dmnd Mtch Hd, 13cm
3.0mm Mtch Hd, 13cm
3.0mm Dmnd Mtch Hd, 13cm
3.0mm Crse Dmnd Mtch Hd, 13cm
3.5mm Dmnd Mtch Head, 13cm
4.0mm Dmnd Mtch Hd, 13cm
4.0mm Crse Dmnd Mtch Hd, 13cm
2.5mm Prcsn Mtch Hd, 13cm
3.0mm Prcsn Mtch Hd, 13cm
2.0mm Precision Round, 16cm
3.0mm Precision Round, 16cm
4.0mm Precision Round, 16cm
5.0mm Precision Round, 16cm
2.0mm Round, 16cm
3.0mm Round, 16cm
4.0mm Round, 16cm
2.0mm Coarse Diamond Round, 16cm
3.0mm Coarse Diamond Round, 16cm
4.0mm Coarse Diamond Round, 16cm
4.0mm X-Coarse Diamond Round, 16cm
5.0mm X-Coarse Diamond Round, 16cm
1.5mm Mtch Hd , 16cm
1.5mm Dmnd Mtch Hd, 16cm
2.0mm Mtch Hd , 16cm
2.0mm Dmnd Mtch Hd, 16cm
2.5mm Mtch Hd , 16cm
2.5mm Dmnd Mtch Hd, 16cm
3.0mm Mtch Hd, 16cm
3.0mm Dmnd Mtch Hd, 16cm
3.0mm Crse Dmnd Mtch Hd, 16cm
3.5mm Dmnd Mtch Head, 16cm
4.0mm Dmnd Mtch Hd, 16cm
4.0mm Crse Dmnd Mtch Hd, 16cm
2.5mm Prcsn Mtch Hd, 16cm
3.0mm Prcsn Mtch Hd, 16cm
Model Identifier(s)
5100-004-000
5100-007-000
5100-008-000
5400-005-000
5400-006-000
5400-052-000
5400-207-000
5400-207-000s1
5400-208-000
5400-218-000
5400-410-000
5407-010-200
5407-010-270
5407-010-272
5407-070-011
5407-100-000
5407-107-017
5407-107-017D
5407-107-022
5407-107-022D
5407-120-050
5407-120-052
5407-120-070
5407-120-072
5407-120-450
5407-120-452
5407-120-470
5407-120-472
5407-120-480
5407-120-482
5407-120-484
5407-120-485
5407-120-486
5407-120-490
5407-120-492
5407-120-900
5407-120-950
5407-120-950A
5407-120-950C
5407-120-970
5407-120-970A
5407-120-970C
5407-150-000
5407-200-000
5407-200-00H
5407-300-000
5407-300-100
5407-350-000
5407-FA1-000
5407-FA1-00R
5407-FA1-015
5407-FA1-015SP
5407-FA2-000
5407-FA2-00R
5407-FA2-023
5407-FA2-023SP
5407-FA3-000
5407-FA3-00R
5407-FA3-030
5407-FA3-030SP
5407-NFA-8CM
5407-NFA-9CM
5820-110-020
5820-110-030
5820-110-040
5820-110-050
5820-110-060
5820-110-320
8431-009-030
8431-009-040
8431-012-020D
8431-012-030D
8431-012-040D
8431-013-030DC
8431-013-040DC
8431-013-050DC
8431-107-030D
8431-107-530
8442-009-030
8442-009-040
8442-107-025D
8442-107-030D
8442-107-525
8442-107-530
8450-009-020
8450-009-030
8450-009-040
8450-009-050
8450-010-020
8450-010-030
8450-010-040
8450-012-020DC
8450-012-030DC
8450-012-040DC
8450-013-040DX
8450-013-050DX
8450-107-015
8450-107-015D
8450-107-020
8450-107-020D
8450-107-025
8450-107-025D
8450-107-030
8450-107-030D
8450-107-030DC
8450-107-035D
8450-107-040D
8450-107-040DC
8450-107-525
8450-107-530
8470-009-020
8470-009-030
8470-009-040
8470-009-050
8470-010-020
8470-010-030
8470-010-040
8470-012-020DC
8470-012-030DC
8470-012-040DC
8470-013-040DX
8470-013-050DX
8470-107-015
8470-107-015D
8470-107-020
8470-107-020D
8470-107-025
8470-107-025D
8470-107-030
8470-107-030D
8470-107-030DC
8470-107-035D
8470-107-040D
8470-107-040DC
8470-107-525
8470-107-530