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Acumed Acu-Loc 2 Wrist Plating System - HSA Registration DE0016490

Access comprehensive regulatory information for Acumed Acu-Loc 2 Wrist Plating 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 DE0016490 and owned by Acumed LLC. The device was registered on November 04, 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
DE0016490
Acumed Acu-Loc 2 Wrist Plating System
HSA Registration Number: DE0016490
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Product Description

It includes plates, screws and accessories designed to provide fixation during fractures, fusions and osteotomies for the radius and ulna.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Orthopaedics
HSA Product Code
HSAMDC00107
HS Code
90211000
Registration Information
Registration Number
DE0016490
Registration Date
November 04, 2014
Change Notification Approval Date
August 24, 2022
Retention Due Date
November 03, 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)
Acu-Loc 2 VDR Plt Extension Link Screw 3.5mm x 8mm Locking Hexalobe Screw 3.5mm x 10mm Locking Hexalobe Screw 3.5mm x 12mm Locking Hexalobe Screw 3.5mm x 14mm Locking Hexalobe Screw 3.5mm x 16mm Locking Hexalobe Screw 3.5mm x 18mm Locking Hexalobe Screw 3.5mm x 10mm Non-Locking Hexalobe Screw 3.5mm x 12mm Non-Locking Hexalobe Screw 3.5mm x 14mm Non-Locking Hexalobe Screw 3.5mm x 16mm Non-Locking Hexalobe Screw 3.5mm x 18mm Non-Locking Hexalobe Screw Frag-Loc Compression Sleeve Frag-Loc Compression Screw Frag-Loc Compression Screw, Long 2.3mm x 14mm Variable Angle Locking Screw 2.3mm x 16mm Variable Angle Locking Screw 2.3mm x 18mm Variable Angle Locking Screw 2.3mm x 20mm Variable Angle Locking Screw 2.3mm x 22mm Variable Angle Locking Screw 2.3mm x 24mm Variable Angle Locking Screw 2.3mm x 26mm Variable Angle Locking Screw 2.3mm x 28mm Variable Angle Locking Screw Acu-Loc VDU Plate Left Std Acu-Loc VDU Plate Right Std Acu-Loc VDU Plate Left Long Acu-Loc VDU Plate Right Long Acu-Loc Dorsal Plate Left Std Acu-Loc Dorsal Plate Right Std Acu-Loc Dorsal Plate Narrow Left Acu-Loc Dorsal Plate Narrow Right Acu-Loc EX Standard Plate Acu-Loc EX Narrow Plate Divergent Radial Styloid Plate Volar Lunate Suture Plate Dorsal Rim Buttress Plate, Right Dorsal Rim Buttress Plate, Left Dorsal Lunate Plate, Right Dorsal Lunate Plate, Left Acu-Loc 2 VDR Prox Plt, Std, L Acu-Loc 2 VDR Prox Plt, Std, R Acu-Loc 2 VDR Prox Plt, Narrow, L Acu-Loc 2 VDR Prox Plt, Narrow, R Acu-Loc 2 VDR Prox Plt, Wide, L Acu-Loc 2 VDR Prox Plt, Wide, R Acu-Loc 2 VDR Plt, Std, L Acu-Loc 2 VDR Plt, Std, R Acu-Loc 2 VDR Plt, Narrow, L Acu-Loc 2 VDR Plt, Narrow, R Acu-Loc 2 VDR Plt, Wide, L Acu-Loc 2 VDR Plt, Wide, R Acu-Loc 2 VDR Extension Plt, Neutral Acu-Loc 2 VDR Extension Plt, Long, L Acu-Loc 2 VDR Extension Plt, Long, R Acu-Loc 2 VDR Plt, Std Long, L Acu-Loc 2 VDR Plt, Std Long, R Acu-Loc 2 VDR Plt, Narrow Long, L Acu-Loc 2 VDR Plt, Narrow Long, R Acu-Loc 2 VDR Prox Plt, Std Long, L Acu-Loc 2 VDR Prox Plt, Std Long, R Acu-Loc 2 VDR Prox Plt, Narrow Long, L Acu-Loc 2 VDR Prox Plt, Narrow Long, R Dorsal T-Guide Locking Bolt Acu-Loc Dorsal T-Guide Std Left 80-0150 Acu-Loc Dorsal T-Guide Std Right  80-0151 Acu-Loc Dorsal T-Guide Narrow Left   80-0154 Acu-Loc Dorsal T-Guide Narrow Right  80-0155 Acu-Loc EX T-Guide Std 2.0mm Locking Drill Guide 4mm-32mm Acu-Loc EX T-Guide Narrow 2.0mm Quick Release Surgibit® Drill Universal Tray Screw Insert Base 2.3mm Bone Tap Small Plate Bender 2.8mm Locking Drill Guide 6-65mm 2.8mm Quick Release Surgibit Drill 2.0mm Locking Drill Guide 6mm-46mm 1.5mm Easyout, QR 2.5mm Easyout, QR Depth Gage 6-65mm Medium Ratcheting Driver Handle Acu-Loc 2 System Case Lid Acu-Loc® 2 System Case Base Acu-Loc 2 VDR T-Guide Locking Bolt .054 K-Wire Guide Periostal Elevator 7.5" x 6mm Str. Edge Acu-Loc 2 VDR T-Guide Std R Acu-Loc 2 VDR T-Guide Std L Acu-Loc 2 VDR T-Guide Narrow R Acu-Loc 2 VDR T-Guide Narrow L Acu-Loc 2 VDR T-Guide Wide R Acu-Loc 2 VDR T-Guide Wide L Acu-Loc 2 VDR Proximal T-Guide Std R Acu-Loc 2 VDR Proximal T-Guide Std L Acu-Loc 2 VDR Proximal T-Guide Narrow R Acu-Loc 2 VDR Proximal T-Guide Narrow L Acu-Loc 2 VDR Proximal T-Guide Wide R Acu-Loc 2 VDR Proximal T-Guide Wide L KickStand Post 5° KickStand Post 10° KickStand Post 15° KickStand Post 20 ° KickStand Post 25° Bone Reduction Forceps 6 3/4" Frag-Loc 2.5mm Drill Fragment Reduction Tool Frag-Loc Depth Gauge 2.3mm Screw Sleeve, Locking Tab 1.5mm Hex Driver Tip, Locking Groove VDR Plate Positioning Handle Assembly Frag-Loc 2.5mm Drill Guide KickStand Post 5°-30° Locking bolt 10-32 (goes with the VDR plate positioning handle) 2.3 Screw Caddy 3.5 Screw Caddy 2.3mm Variable Angle Screw Caddy Base Acu-Loc 2 Implant Platter Hand & Wrist General Instrument Platter Hand & Wrist Platter Lid Heiss retractor Frag-Loc 1.5mm Cannulated Driver Assy T15 Stick Fit Hexalobe Driver 2.3mm Variable Angle Drill Guide 2.3mm Variable Angle Drill Guide Driver Hand & Wrist Implant Platter 2.3mm/3.5mm Screw Caddy Lid Distal Radius Fragment Specific Insert 2.3mm Long Screw Caddy Base 2.3mm Long Screw Caddy Lid 1.7mm Quick Coupler Semi-Fluted Drill Mini-AO Torque Limiting Driver, 10inlb 2.3mm Variable Angle Screw Insert 2.3mm Variable Angle Screw Caddy Lid 2.3mm Screw Depth Gauge 6-46mm Acu-Loc® Dorsal Add-On X-Ray Template Acu-Loc® VDU Add-On X-Ray Template Acu-Loc® EX Add-On X-Ray Template Acu-Loc® 2 VDR Plt X-Ray Template Acu-Loc® 2 VDR Prox Plt X-Ray Template Acu-Loc® 2 Extension Plt X-Ray Template Acu-Loc® 2 Frag-Loc™ X-Ray Template 3.5mm x 10.0mm Cortical Screw 3.5mm x 12.0mm Cortical Screw 3.5mm x 14.0mm Cortical Screw 3.5mm x 16.0mm Cortical Screw 3.5mm x 18.0mm Cortical Screw 2.3mm x 8mm Non-Toggling Cortical Screw 2.3mm x 10mm Non-Toggling Cortical Screw 2.3mm x 12mm Non-Toggling Cortical Screw 2.3mm x 14mm Non-Toggling Cortical Screw 2.3mm x 16mm Non-Toggling Cortical Screw 2.3mm x 18mm Non-Toggling Cortical Screw 2.3mm x 20mm Non-Toggling Cortical Screw 2.3mm x 22mm Non-Toggling Cortical Screw 2.3mm x 24mm Non-Toggling Cortical Screw 2.3mm x 26mm Non-Toggling Cortical Screw 2.3mm x 28mm Non-Toggling Cortical Screw 2.3mm x 30mm Non-Toggling Cortical Screw 2.3mm x 32mm Non-Toggling Cortical Screw 2.3mm x 34mm Non-Toggling Cortical Screw 2.3mm x 36mm Non-Toggling Cortical Screw 2.3mm x 38mm Non-Toggling Cortical Screw 2.3mm x 40mm Non-Toggling Cortical Screw 2.3mm x 42mm Non-Toggling Cortical Screw 2.3mm x 44mm Non-Toggling Cortical Screw 2.3mm x 46mm Non-Toggling Cortical Screw 2.3mm x 8mm Locking Cortical Peg 2.3mm x 10mm Locking Cortical Peg 2.3mm x 12mm Locking Cortical Peg 2.3mm x 14mm Locking Cortical Peg 2.3mm x 16mm Locking Cortical Peg 2.3mm x 18mm Locking Cortical Peg 2.3mm x 20mm Locking Cortical Peg 2.3mm x 22mm Locking Cortical Peg 2.3mm x 24mm Locking Cortical Peg 2.3mm x 26mm Locking Cortical Peg 2.3mm x 28mm Locking Cortical Peg 2.3mm x 8mm Locking Cortical Screw 2.3mm x 10mm Locking Cortical Screw 2.3mm x 12mm Locking Cortical Screw 2.3mm x 14mm Locking Cortical Screw 2.3mm x 16mm Locking Cortical Screw 2.3mm x 18mm Locking Cortical Screw 2.3mm x 20mm Locking Cortical Screw 2.3mm x 22mm Locking Cortical Screw 2.3mm x 24mm Locking Cortical Screw 2.3mm x 26mm Locking Cortical Screw 2.3mm x 28mm Locking Cortical Screw 2.3mm x 30mm Locking Cortical Screw 2.3mm x 32mm Locking Cortical Screw 2.3mm Locking Cortical Screw (34mm) 2.3mm Locking Cortical Screw (36mm) 2.3mm Locking Cortical Screw (38mm) 2.3mm Locking Cortical Screw (40mm) 2.3mm Locking Cortical Screw (42mm) 2.3mm Locking Cortical Screw (44mm) 2.3mm Locking Cortical Screw (46mm) 3.5mm x 8.0mm Locking Cortical Screw 3.5mm x 10.0mm Locking Cortical Screw 3.5mm x 12.0mm Locking Cortical Screw 3.5mm x 14.0mm Locking Cortical Screw 3.5mm x 16.0mm Locking Cortical Screw 3.5mm x 18.0mm Locking Cortical Screw 2.5mm Quick Release Hex Driver 8" Bone Reduction Forceps Cruciform Driver Handle 15mm Hohman Retractor (baby bennett) Drill Guide / Depth Gage for 2.0mm Drill Distal Radius Probe 3.5mm Screw Driver Sleeve 2.0mm / 2.8mm Thin Drill Guide Sharp Hook Plt tacks .035" x 5.75" ST Guide Wire .054" X 6" Guide Wire
Model Identifier(s)
30-0093 30-0232 30-0233 30-0234 30-0235 30-0236 30-0237 30-0256 30-0257 30-0258 30-0259 30-0260 30-0370 30-0371 30-0372 30-2314 30-2316 30-2318 30-2320 30-2322 30-2324 30-2326 30-2328 70-0045 70-0046 70-0047 70-0048 70-0055 70-0056 70-0057 70-0058 70-0063 70-0064 70-0331 70-0334 70-0335 70-0336 70-0337 70-0338 70-0350 70-0351 70-0352 70-0353 70-0354 70-0355 70-0356 70-0357 70-0358 70-0359 70-0360 70-0361 70-0364 70-0365 70-0366 70-0368 70-0369 70-0370 70-0371 70-0372 70-0373 70-0382 70-0383 80-0038 80-0150 80-0151 80-0154 80-0155 80-0166 80-0249 80-0274 80-0318 80-0346 80-0362 80-0363 80-0384 80-0387 80-0592 80-0598 80-0600 80-0623 80-0663 80-0673 80-0674 80-0682 80-0688 80-0693 80-0694 80-0695 80-0696 80-0697 80-0698 80-0699 80-0700 80-0701 80-0702 80-0703 80-0704 80-0705 80-0718 80-0719 80-0720 80-0721 80-0722 80-0723 80-0724 80-0725 80-0726 80-0727 80-0728 80-0729 80-0730 80-0731 80-0738 80-0748 80-0749 80-0751 80-0752 80-0754 80-0755 80-0756 80-0758 80-0760 80-0762 80-0763 80-0787 80-0790 80-0822 80-0825 80-0826 80-0868 80-1008 80-1009 80-1010 80-1356 90-0007 90-0014 90-0015 90-0030 90-0031 90-0032 90-0033 CO-3100 CO-3120 CO-3140 CO-3160 CO-3180 CO-N2308 CO-N2310 CO-N2312 CO-N2314 CO-N2316 CO-N2318 CO-N2320 CO-N2322 CO-N2324 CO-N2326 CO-N2328 CO-N2330 CO-N2332 CO-N2334 CO-N2336 CO-N2338 CO-N2340 CO-N2342 CO-N2344 CO-N2346 CO-S2308 CO-S2310 CO-S2312 CO-S2314 CO-S2316 CO-S2318 CO-S2320 CO-S2322 CO-S2324 CO-S2326 CO-S2328 CO-T2308 CO-T2310 CO-T2312 CO-T2314 CO-T2316 CO-T2318 CO-T2320 CO-T2322 CO-T2324 CO-T2326 CO-T2328 CO-T2330 CO-T2332 CO-T2334 CO-T2336 CO-T2338 CO-T2340 CO-T2342 CO-T2344 CO-T2346 COL-3080 COL-3100 COL-3120 COL-3140 COL-3160 COL-3180 HPC-0025 MS-1280 MS-2210 MS-46827 MS-DG23 MS-DRPB MS-SS35 PL-2118 PL-CL06 PL-PTACK WS-0906ST WS-1406ST