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Acumed Acutrak 2 Screw System - HSA Registration DE0016363

Access comprehensive regulatory information for Acumed Acutrak 2 Screw System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0016363 and owned by Acumed LLC. The device was registered on September 30, 2014.

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 C
DE0016363
Acumed Acutrak 2 Screw System
HSA Registration Number: DE0016363
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Product Description

Acutrak 2 Micro, Mini, Standard, 4.7, and 5.5 Screws are intended as a fixation device for small bones, bone fragments, and osteotomies. It is not intended for interference or soft tissue fixation. Acutrak 2 7.5 screws are intended as a fixation device. May be used for fusions, fractures, or osteotomies of the clavicle, humerus, radius, ulna, ilium, femur, patella, fibula, tibia, talus, malleolus, and calcaneous.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Orthopaedics
HSA Product Code
HSAMDC00107
HS Code
90211000
Registration Information
Registration Number
DE0016363
Registration Date
September 30, 2014
Change Notification Approval Date
August 24, 2022
Retention Due Date
September 29, 2025
Product Owner
Short Name
Acumed LLC
Address
5885 N.W. Cornelius Pass Road, Hillsboro, Oregon 97124, USA, UNITED STATES
Registrant
Address
47 JALAN BUROH, #09-01, SINGAPORE 619491
Importer
Address
47 JALAN BUROH, #09-01, SINGAPORE 619491
Model Information
Model Name(s)
25.0mm Acutrak 2 - 5.5 Screw 30.0mm Acutrak 2 - 5.5 Screw 35.0mm Acutrak 2 - 5.5 Screw 40.0mm Acutrak 2 - 5.5 Screw 45.0mm Acutrak 2 - 5.5 Screw 50.0mm Acutrak 2 - 5.5 Screw 55.0mm Acutrak 2 - 5.5 Screw 60.0mm Acutrak 2 - 5.5 Screw 20.0mm Acutrak 2® - 4.7 Screw 22.0mm Acutrak 2® - 4.7 Screw 24.0mm Acutrak 2® - 4.7 Screw 26.0mm Acutrak 2® - 4.7 Screw 28.0mm Acutrak 2® - 4.7 Screw 30.0mm Acutrak 2® - 4.7 Screw 35.0mm Acutrak 2® - 4.7 Screw 40.0mm Acutrak 2® - 4.7 Screw 45.0mm Acutrak 2® - 4.7 Screw 50.0mm Acutrak 2® - 4.7 Screw 40.0mm Acutrak 2® - 7.5 Screw 45.0mm Acutrak 2® - 7.5 Screw 50.0mm Acutrak 2® - 7.5 Screw 55.0mm Acutrak 2® - 7.5 Screw 60.0mm Acutrak 2® - 7.5 Screw 65.0mm Acutrak 2® - 7.5 Screw 70.0mm Acutrak 2® - 7.5 Screw 75.0mm Acutrak 2® - 7.5 Screw 80.0mm Acutrak 2® - 7.5 Screw 85.0mm Acutrak 2® - 7.5 Screw 90.0mm Acutrak 2® - 7.5 Screw 95.0mm Acutrak 2® - 7.5 Screw 100.0mm Acutrak 2® - 7.5 Screw 105.0mm Acutrak 2® - 7.5 Screw 110.0mm Acutrak 2® - 7.5 Screw 115.0mm Acutrak 2® - 7.5 Screw 120.0mm Acutrak 2® - 7.5 Screw Micro-Acutrak 2 Drill, Long Acutrak 2 Std Trephine Acutrak 2 Mini Trephine Acutrak 2 Micro Trephine Acutrak 2 5.5 Trephine Broken 4.0 CA Trephine Broken 3.5 CO Trephine Broken 2.7 CO Trephine A/O Quick Release Handle Drill, Left Hand 1.5mm, QR Drill, Left Hand 2.0mm, QR Drill, Left Hand 2.5mm, QR Drill, Left Hand 3.0mm, QR Drill, Left Hand 3.5mm, QR Drill, Left Hand 4.0mm, QR AT2 Micro Instrument Module .062" X 8" Single Trocar Guide Wire 1.5mm Solid Hex Driver Tip, QR Acutrak® Screw Removal Tray Assy Acutrak® Screw Removal Tray Base Acutrak® Screw Removal Tray Lid 1.5mm Easyout, QR 2.0mm Easyout, QR 2.5mm Easyout, QR 3.0mm Easyout, QR 3.5mm Easyout, QR 4.0mm Easyout, QR 3.0mm Hex Impact Screw Extractor 4.0mm Hex Impact Screw Extractor Impact Driver Handle Removal Tip Shaft, QR Removal Tip Wrench Micro Removal Tip Mini Removal Tip Std Removal Tip Large Removal Tip Extra-Large Removal Tip Locking Pliers, Small 2.0mm Solid Hex Driver Tip, QR 3.0mm Solid Hex Driver Tip, QR 3.5mm Solid Hex Driver Tip, QR 4.0mm Solid Hex Driver Tip, QR Cruciform Driver Tip, QR T-Handle, Small, Fixed, QR Connector Medium Ratcheting Driver Handle Univ AT2 Std Mini & Micro Inst Base Univ AT2 Shallow Lid Univ AT2 Std Mini & Micro Inst Tray Univ AT2 Std Mini & Micro Imp Base Univ AT2 Deep Lid Univ AT2 Std Mini & Micro Inst & Imp Try Large Acutrak 2® Drills & Driver Platter Large Acutrak 2® Common Inst. Platter Large Acutrak 2® 4.7 & 5.5 Screw Platter Large Acutrak 2® 7.5 Screw Platter Large Acutrak 2® 4.7 Screw Caddy Large Acutrak 2® 5.5 Screw Caddy Large Acutrak 2® 7.5 Screw Caddy Large Acutrak 2® Screw 2x2 Base Large Acutrak 2® Screw Lid ACUTRAK 2® 4.7 PROFILE DRILL ACUTRAK 2® 4.7 LONG DRILL 1.6mm (.062") x 9.25" GUIDE WIRE ACUTRAK 2® 5.5 PROFILE DRILL ACUTRAK 2® 5.5 LONG DRILL Can Driver, 3.0mm Acutrak 2 Driver, 3.0mm Acutrak 2 2.4mm (.094") X 9.25" GUIDE WIRE 2.4mm (.094") X 9.25" GUIDE WIRE, THREADED ACUTRAK 2® 7.5 PROFILE DRILL ACUTRAK 2® 7.5 LONG DRILL Can Driver, 4.0mm Acutrak 2 6" long Driver, 4.0mm Acutrak 2 4.0mm Cann QR Hex Driver Tip AT2, Short Large Acutrak 2® Soft Tissue Protector .062" (1.6mm) Guide Wire Probe .094" (2.4mm) Guide Wire Probe Large Acutrak 2® Screw Sizer Ratchet T-Handle with A/O Connection Micro Acutrak 2® Extended Long Drill Micro Acutrak 2® Screw Sizer .035 x 6 in Single Trocar Guide Wire .035 x 6 in Double Trocar Guide Wire Micro Acutrak 2® Extension Caddy Micro Acutrak 2® Extension Platter Micro Acutrak 2® Extension Platter Lid Acutrak 2® - 5.5 X-Ray Template Acutrak 2® - 4.7 X-Ray Template Acutrak 2® - 7.5 X-Ray Template Acutrak 2® Standard X-Ray Template Acutrak 2® Micro X-Ray Template Acutrak 2® Mini X-Ray Template Forceps Acutrak Arthroscopic Cannula Assembly Acutrak Plunger Assy. Acutrak 2 Instrumentation Set Acutrak 2 Tray Assembly AT2 Probe Acutrak 2 Standard Screw Caddy Acutrak 2 Mini Screw Caddy Acutrak 2 Micro Screw Caddy Micro-Acutrak 2 Drill Acutrak 2 Drill .035 Dia. Parallel Wire Guide Assembly .045 Dia. Parallel Wire Guide Assembly .054 Dia. Parallel Wire Guide Assembly 8.0mm, Micro Acutrak 2 Bone Screw 9.0mm, Micro Acutrak 2 Bone Screw 10.0mm, Micro Acutrak 2 Bone Screw 11.0mm, Micro Acutrak 2 Bone Screw 12.0mm, Micro Acutrak 2 Bone Screw 13.0mm, Micro Acutrak 2 Bone Screw 14.0mm, Micro Acutrak 2 Bone Screw 16.0mm, Micro Acutrak 2 Bone Screw 18.0mm, Micro Acutrak 2 Bone Screw 20.0mm, Micro Acutrak 2 Bone Screw 22.0mm, Micro Acutrak 2 Bone Screw 24.0mm, Micro Acutrak 2 Bone Screw 26.0mm, Micro Acutrak 2 Bone Screw 28.0mm, Micro Acutrak 2 Bone Screw 30.0mm, Micro Acutrak 2 Bone Screw Acutrak 2 Micro Satellite Tray Acutrak 2 Drill, Long 16.0mm, Mini Acutrak 2 Bone Screw 18.0mm, Mini Acutrak 2 Bone Screw 20.0mm, Mini Acutrak 2 Bone Screw 22.0mm, Mini Acutrak 2 Bone Screw 24.0mm, Mini Acutrak 2 Bone Screw 26.0mm, Mini Acutrak 2 Bone Screw 28.0mm, Mini Acutrak 2 Bone Screw 30.0mm, Mini Acutrak 2 Bone Screw Acutrak 2 Mini Satellite Tray Assembly 16.0mm, Standard Acutrak 2 Bone Screw 18.0mm, Standard Acutrak 2 Bone Screw 20.0mm, Standard Acutrak 2 Bone Screw 22.0mm, Standard Acutrak 2 Bone Screw 24.0mm, Standard Acutrak 2 Bone Screw 26.0mm, Standard Acutrak 2 Bone Screw 28.0mm, Standard Acutrak 2 Bone Screw 30.0mm, Standard Acutrak 2 Bone Screw 32.0mm, Standard Acutrak 2 Bone Screw 34.0mm, Standard Acutrak 2 Bone Screw Acutrak 2 Standard Satellite Tray AT2 Screw Sizer Mini-Acutrak 2 Drill Mini-Acutrak 2 Drill, Long 6mm Graft Removal Paddle Assy. 2.5mm Quick Release Hex Driver 1.5mm Cann. Quick Release Driver Tip 2.0mm Cann. Quick Release Driver Tip 2.5mm Cann. Quick Release, Driver Tip Large Cann. Quick Release Driver Handle Periosteal Elevator, 7.25 .035" Percutaneous Bone Clamp 7mm Bone Graft Drill Assy. SHARP HOOK .035" x 5.75" ST Guide Wire .045" x 6" ST Guide Wire .054" x 7" ST Guide Wire
Model Identifier(s)
30-0021-S 30-0023-S 30-0025-S 30-0027-S 30-0029-S 30-0031-S 30-0084-S 30-0085-S 30-0620-S 30-0622-S 30-0624-S 30-0626-S 30-0628-S 30-0630-S 30-0635-S 30-0640-S 30-0645-S 30-0650-S 30-0740-S 30-0745-S 30-0750-S 30-0755-S 30-0760-S 30-0765-S 30-0770-S 30-0775-S 30-0780-S 30-0785-S 30-0790-S 30-0795-S 30-0800-S 30-0805-S 30-0810-S 30-0815-S 30-0820-S 80-0100 80-0211 80-0212 80-0213 80-0214 80-0215 80-0216 80-0217 80-0398 80-0399 80-0400 80-0401 80-0402 80-0403 80-0404 80-0405 80-0413 80-0583 80-0586 80-0587 80-0588 80-0598 80-0599 80-0600 80-0601 80-0602 80-0603 80-0605 80-0606 80-0607 80-0610 80-0611 80-0612 80-0613 80-0614 80-0615 80-0616 80-0617 80-0632 80-0633 80-0634 80-0635 80-0636 80-0637 80-0663 80-0808 80-0809 80-0810 80-0811 80-0812 80-0813 80-0870 80-0871 80-0876 80-0877 80-0878 80-0880 80-0882 80-0884 80-0885 80-0945 80-0946 80-0950 80-0955 80-0956 80-0958 80-0959 80-0970 80-0971 80-0975 80-0976 80-0978 80-0979 80-0980 80-0990 80-0992 80-0994 80-0996 80-0999 80-1522 80-1523 80-1524 80-1525 80-1526 80-1527 80-1534 90-0017 90-0034 90-0035 ACT70-01 ACT70-02 ACT70-03 AT-7005 AT-7025 AT-7060 AT2-0000 AT2-0001 AT2-0402 AT2-055 AT2-066 AT2-077 AT2-1509 AT2-2515 AT2-3500 AT2-4500 AT2-5400 AT2-C08-S AT2-C09-S AT2-C10-S AT2-C11-S AT2-C12-S AT2-C13-S AT2-C14-S AT2-C16-S AT2-C18-S AT2-C20-S AT2-C22-S AT2-C24-S AT2-C26-S AT2-C28-S AT2-C30-S AT2-C700 AT2-L2515 AT2-M16-S AT2-M18-S AT2-M20-S AT2-M22-S AT2-M24-S AT2-M26-S AT2-M28-S AT2-M30-S AT2-M600 AT2-S16-S AT2-S18-S AT2-S20-S AT2-S22-S AT2-S24-S AT2-S26-S AT2-S28-S AT2-S30-S AT2-S32-S AT2-S34-S AT2-S500 AT2-SMCZ AT2M-1813 AT2M-L1813 BG-8064 HPC-0025 HT-0915 HT-1120 HT-1725 MS-3200 MS-46211 MS-CL35 PL-BG07 PL-CL06 WS-0906ST WS-1106ST WS-1407ST