SBi AutoFIX Cannulated Compression Screw System (Non-Sterile) - HSA Registration DE0006937
Access comprehensive regulatory information for SBi AutoFIX Cannulated Compression Screw System (Non-Sterile) in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0006937 and owned by Stryker GmbH. The device was registered on June 08, 2011.
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 C
DE0006937
SBi AutoFIX Cannulated Compression Screw System (Non-Sterile)
HSA Registration Number: DE0006937
Product Description
The cannulated screws are primarily intended for permanent implantation in these areas: - scaphoid fractures - carpal fractures and fusions - metacarpal fractures and osteotomies - distal radius fractures (particular fragments) - ulnar styloid fractures - radial head fractures - capitellum fractures - humeral head fractures - glenoid fractures - intercarpal distal and proximal fusions - periarticular phalangeal fractures - metatarsal fractures and osteotomies - tarsal fusions - tarsal fractures - malleolar fractures - patellar fractures - osteochondral fractures - talo-navicular fusions - tibeo-talar fusions - cuboid fusions. The cannulated screws are indicated in the treatment of fractures, non-unions, pseudoarthrosis and degenerative changes as well as corrective osteotomies geared towards a functionally stable osteosynthesis in small bones.
Device Classification
Device Class
CLASS C
Medical Speciality Area
Orthopaedics
HSA Product Code
HSAMDC00107
HS Code
90211000
Registration Information
Registration Number
DE0006937
Registration Date
June 08, 2011
Change Notification Approval Date
August 02, 2021
Retention Due Date
June 07, 2025
Product Owner
Registrant
Address
1 GEORGE STREET, ONE GEORGE STREET, #20-1/2/3, SINGAPORE 049145
Importer
Address
47 JALAN BUROH, #09-01, SINGAPORE 619491
1 GEORGE STREET, ONE GEORGE STREET, #20-1/2/3, SINGAPORE 049145
Model Information
Model Name(s)
2.0 X 10 mm AutoFIX, stainless steel cannulated low compression screw
2.0 X 12 mm AutoFIX, stainless steel cannulated low compression screw
2.0 X 14 mm AutoFIX, stainless steel cannulated low compression screw
2.0 X 16 mm AutoFIX, stainless steel cannulated low compression screw
2.0 X 18 mm AutoFIX, stainless steel cannulated low compression screw
2.0 X 20 mm AutoFIX, stainless steel cannulated low compression screw
2.0 X 22 mm AutoFIX, stainless steel cannulated low compression screw
2.0 X 24 mm AutoFIX, stainless steel cannulated low compression screw
2.0 X 26 mm AutoFIX, stainless steel cannulated low compression screw
2.0 X 28 mm AutoFIX, stainless steel cannulated low compression screw
2.0 X 30 mm AutoFIX, stainless steel cannulated low compression screw
2.5 X 10 mm AutoFIX, stainless steel cannulated low compression screw
2.5 X 12 mm AutoFIX, stainless steel cannulated low compression screw
2.5 X 14 mm AutoFIX, stainless steel cannulated low compression screw
2.5 X 16 mm AutoFIX, stainless steel cannulated low compression screw
2.5 X 18 mm AutoFIX, stainless steel cannulated low compression screw
2.5 X 20 mm AutoFIX, stainless steel cannulated low compression screw
2.5 X 24 mm AutoFIX, stainless steel cannulated low compression screw
2.5 X 26 mm AutoFIX, stainless steel cannulated low compression screw
2.5 X 28 mm AutoFIX, stainless steel cannulated low compression screw
2.5 X 30 mm AutoFIX, stainless steel cannulated low compression screw
3.0 X 12 mm AutoFIX, stainless steel cannulated low compression screw
3.0 X 14 mm AutoFIX, stainless steel cannulated low compression screw
3.0 X 16 mm AutoFIX, stainless steel cannulated low compression screw
3.0 X 18 mm AutoFIX, stainless steel cannulated low compression screw
3.0 X 20 mm AutoFIX, stainless steel cannulated low compression screw
3.0 X 22 mm AutoFIX, stainless steel cannulated low compression screw
3.0 X 24 mm AutoFIX, stainless steel cannulated low compression screw
3.0 X 26 mm AutoFIX, stainless steel cannulated low compression screw
3.0 X 28 mm AutoFIX, stainless steel cannulated low compression screw
3.0 X 30 mm AutoFIX, stainless steel cannulated low compression screw
3.0 X 32 mm AutoFIX, stainless steel cannulated low compression screw
3.0 X 34 mm AutoFIX, stainless steel cannulated low compression screw
3.0 X 36 mm AutoFIX, stainless steel cannulated low compression screw
3.0 X 38 mm AutoFIX, stainless steel cannulated low compression screw
3.0 X 40 mm AutoFIX, stainless steel cannulated low compression screw
4.0 X 20 mm AutoFIX, stainless steel cannulated low compression screw
4.0 X 22 mm AutoFIX, stainless steel cannulated low compression screw
4.0 X 24 mm AutoFIX, stainless steel cannulated low compression screw
4.0 X 26 mm AutoFIX, stainless steel cannulated low compression screw
4.0 X 28 mm AutoFIX, stainless steel cannulated low compression screw
4.0 X 30 mm AutoFIX, stainless steel cannulated low compression screw
4.0 X 32 mm AutoFIX, stainless steel cannulated low compression screw
4.0 X 34 mm AutoFIX, stainless steel cannulated low compression screw
4.0 X 36 mm AutoFIX, stainless steel cannulated low compression screw
4.0 X 38 mm AutoFIX, stainless steel cannulated low compression screw
4.0 X 40 mm AutoFIX, stainless steel cannulated low compression screw
4.0 X 42 mm AutoFIX, stainless steel cannulated low compression screw
4.0 X 44 mm AutoFIX, stainless steel cannulated low compression screw
4.0 X 46 mm AutoFIX, stainless steel cannulated low compression screw
4.0 X 48 mm AutoFIX, stainless steel cannulated low compression screw
4.0 X 50 mm AutoFIX, stainless steel cannulated low compression screw
2.5 X 22 mm AutoFIX, stainless steel cannulated low compression screw
2.0 X 10 mm AutoFIX, Titanium cannulated low compression screw
2.0 X 12 mm AutoFIX, Titanium cannulated low compression screw
2.0 X 14 mm AutoFIX, Titanium cannulated low compression screw
2.0 X 16 mm AutoFIX, Titanium cannulated low compression screw
2.0 X 18 mm AutoFIX, Titanium cannulated low compression screw
2.0 X 20 mm AutoFIX, Titanium cannulated low compression screw
2.0 X 22 mm AutoFIX, Titanium cannulated low compression screw
2.0 X 24 mm AutoFIX, Titanium cannulated low compression screw
2.0 X 26 mm AutoFIX, Titanium cannulated low compression screw
2.0 X 28 mm AutoFIX, Titanium cannulated low compression screw
2.0 X 30 mm AutoFIX, Titanium cannulated low compression screw
2.5 X 10 mm AutoFIX, Titanium cannulated low compression screw
2.5 X 12 mm AutoFIX, Titanium cannulated low compression screw
2.5 X 14 mm AutoFIX, Titanium cannulated low compression screw
2.5 X 16 mm AutoFIX, Titanium cannulated low compression screw
2.5 X 18 mm AutoFIX, Titanium cannulated low compression screw
2.5 X 20 mm AutoFIX, Titanium cannulated low compression screw
2.5 X 22 mm AutoFIX, Titanium cannulated low compression screw
2.5 X 24 mm AutoFIX, Titanium cannulated low compression screw
2.5 X 26 mm AutoFIX, Titanium cannulated low compression screw
2.5 X 28 mm AutoFIX, Titanium cannulated low compression screw
2.5 X 30 mm AutoFIX, Titanium cannulated low compression screw
3.0 X 12 mm AutoFIX, Titanium cannulated low compression screw
3.0 X 14 mm AutoFIX, Titanium cannulated low compression screw
3.0 X 16 mm AutoFIX, Titanium cannulated low compression screw
3.0 X 18 mm AutoFIX, Titanium cannulated low compression screw
3.0 X 20 mm AutoFIX, Titanium cannulated low compression screw
3.0 X 22 mm AutoFIX, Titanium cannulated low compression screw
3.0 X 24 mm AutoFIX, Titanium cannulated low compression screw
3.0 X 26 mm AutoFIX, Titanium cannulated low compression screw
3.0 X 28 mm AutoFIX, Titanium cannulated low compression screw
3.0 X 30 mm AutoFIX, Titanium cannulated low compression screw
3.0 X 32 mm AutoFIX, Titanium cannulated low compression screw
3.0 X 34 mm AutoFIX, Titanium cannulated low compression screw
3.0 X 36 mm AutoFIX, Titanium cannulated low compression screw
3.0 X 38 mm AutoFIX, Titanium cannulated low compression screw
3.0 X 40 mm AutoFIX, Titanium cannulated low compression screw
4.0 X 20 mm AutoFIX, Titanium cannulated low compression screw
4.0 X 22 mm AutoFIX, Titanium cannulated low compression screw
4.0 X 24 mm AutoFIX, Titanium cannulated low compression screw
4.0 X 26 mm AutoFIX, Titanium cannulated low compression screw
4.0 X 28 mm AutoFIX, Titanium cannulated low compression screw
4.0 X 30 mm AutoFIX, Titanium cannulated low compression screw
4.0 X 32 mm AutoFIX, Titanium cannulated low compression screw
4.0 X 34 mm AutoFIX, Titanium cannulated low compression screw
4.0 X 36 mm AutoFIX, Titanium cannulated low compression screw
4.0 X 38 mm AutoFIX, Titanium cannulated low compression screw
4.0 X 40 mm AutoFIX, Titanium cannulated low compression screw
4.0 X 42 mm AutoFIX, Titanium cannulated low compression screw
4.0 X 44 mm AutoFIX, Titanium cannulated low compression screw
4.0 X 46 mm AutoFIX, Titanium cannulated low compression screw
4.0 X 48 mm AutoFIX, Titanium cannulated low compression screw
4.0 X 50 mm AutoFIX, Titanium cannulated low compression screw
6.5 X 100 mm AutoFIX, Titanium cannulated compression screw
6.5 X 40 mm AutoFIX, Titanium cannulated compression screw
6.5 X 45 mm AutoFIX, Titanium cannulated compression screw
6.5 X 50 mm AutoFIX, Titanium cannulated compression screw
6.5 X 55 mm AutoFIX, Titanium cannulated compression screw
6.5 X 60 mm AutoFIX, Titanium cannulated compression screw
6.5 X 65 mm AutoFIX, Titanium cannulated compression screw
6.5 X 70 mm AutoFIX, Titanium cannulated compression screw
6.5 X 75 mm AutoFIX, Titanium cannulated compression screw
6.5 X 80 mm AutoFIX, Titanium cannulated compression screw
6.5 X 85 mm AutoFIX, Titanium cannulated compression screw
6.5 X 90 mm AutoFIX, Titanium cannulated compression screw
6.5 X 95 mm AutoFIX, Titanium cannulated compression screw
1.0mm K-wire 110 mm
K-wire Ø1.8 L150mm
0.91mm SS K-wire 80mm length
AutoFIX Ø2,0/2,5 Stainless Steel Implants & Instrument Set
AutoFIX Ø2,0/2,5 Implants titanium & Instrument Set
International AutoFIX dia. 3.0/4.0mm (base + lid)
AutoFIX Ø3,0/4,0 titanium Instrument Set
AutoFIX Ø3,0/4,0 Stainless Steel Instrument Set
Set instruments AutoFIX Ø6,5
K-wire tube
AutoFIX dia. 2.0/2.5mm (base + lid)
Tray (base+lid)
Mod T10 cannulated screwdriver shaft
Mod T10 remove screwdriver shaft
Cannulated Screw Driver Tip T25
Ø6.5 AutoFIX countersink
Mod T7 Solid Screwdriver
Mod T7 Cannulated Screwdriver Shaft
Cannulated T handle quick coupling
cannulated screwdriver handle
Screwdriver / depht gage (10-30mm) 2 in 1
Countersink dia 4.0 shaft
Countersink dia 3.0 shaft
2.0/2.5mm Cannulated Countersink
K-wire Guide Sleeve, for 0.91mm wire
Ø1.8 k-wire guide
Percutaneus Guide
Depth gage 20-60mm
AutoFIX Ø6.5 depth gage
Depth Gage
Screw forceps
Scarf Forceps
0.8mm cleaning stylet
Model Identifier(s)
141-2010
141-2012
141-2014
141-2016
141-2018
141-2020
141-2022
141-2024
141-2026
141-2028
141-2030
141-2510
141-2512
141-2514
141-2516
141-2518
141-2520
141-2524
141-2526
141-2528
141-2530
141-3012
141-3014
141-3016
141-3018
141-3020
141-3022
141-3024
141-3026
141-3028
141-3030
141-3032
141-3034
141-3036
141-3038
141-3040
141-4020
141-4022
141-4024
141-4026
141-4028
141-4030
141-4032
141-4034
141-4036
141-4038
141-4040
141-4042
141-4044
141-4046
141-4048
141-4050
141.2522
241-2010
241-2012
241-2014
241-2016
241-2018
241-2020
241-2022
241-2024
241-2026
241-2028
241-2030
241-2510
241-2512
241-2514
241-2516
241-2518
241-2520
241-2522
241-2524
241-2526
241-2528
241-2530
241-3012
241-3014
241-3016
241-3018
241-3020
241-3022
241-3024
241-3026
241-3028
241-3030
241-3032
241-3034
241-3036
241-3038
241-3040
241-4020
241-4022
241-4024
241-4026
241-4028
241-4030
241-4032
241-4034
241-4036
241-4038
241-4040
241-4042
241-4044
241-4046
241-4048
241-4050
241-6510
241-6540
241-6545
241-6550
241-6555
241-6560
241-6565
241-6570
241-6575
241-6580
241-6585
241-6590
241-6595
451-0016
451-0031
451-1136
600-0006
600-0008
600-0017
600-0027
600-0028
600-0054
602-1010
603-0000
603-0026
901-0011
901-0012
901-0048
901-0059
901-1016
901-1017
903-0054
903-1006
903-1010
907-0012
907-0013
907-1003
908-0020
908-0098
908-0107
909-0000
909-0022
909-1003
914-0001
914-0030
929-0004