Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014170143

FEI Number

3014170143

Entity Name

3D INSTRUMENTATION SDN BHD

City/State/Country

Bukit Mertajam Pulau Pinang, MY

Establishment Address

No.95, Lorong IKS Juru 5, Taman Perindustrian Ringan Juru, Bukit Mertajam Pulau Pinang 14000, MY

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

3D Instrumentation Sdn Bhd (Owner Number: 10056829)

Owner / Operator Contact Address

No 95, Lorong IKS Juru 5, Taman Perindustrian Ringan Juru,, Bukit Mertajam, Penang, MY-07 14000, MY

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

FO Micro Cleaning Stylet POSITIONER, SOCKET Anterior Mid - Shaft Clavicle Plates MDT Plate 1.4mm Drill Top Hat Dorsal Spanning Plate Distal Fibula Plates 1.4mm Mini Fragment Drill Guide Anterior Lateral Clavicle Plates 2mm Lag Screw Drill Guide Proximal Humerus Plate Superior Distal Clav Plates Superior Midshaft Clavicle Plates OIC Small / Mini Fragment Plate System 3.5mm LAG screw Drill Guide FO Countersink (Cannulated) 3.5 Extended Metaphyseal Cannulated hand drill 3.5 Metaphyseal Cannulated Hand drill 0.6 Single-ended Trocar K-wire 70mm FO Micro Screw (Cannulated) SiLO TFX MIS Sacroiliac Joint Fixation System catalog no. 114-303-0124 SiLO TFX Decorticating Reamer 24mm 1.4 FO Micro Drill (Cannulated) 1.1 FO Micro Drill Extended 3.5mm NX Metaphyseal Cannulated Hand Drill 3.5mm NX Metaphyseal Cannulated Hand Drill Extended 3.5mm NX Metaphyseal Cannulated Hand Drill NX Depth Gauge Lag screw Tissure Protector FO Micro Depth Gauge (Cannulated) NX Depth Gauge Bony Trauma Extremity System (BTES) Screw Range -NX Nail System NX Extremity Nail

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GAH	Stylet, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2020-01-28
KIL	Positioner, Socket	Orthopedic	Class 1	888.4540	2018-01-19
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2024-11-19
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-11-19
JDS	Nail, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-01-06
HWW	Countersink	Orthopedic	Class 1	888.4540	2020-01-28
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2020-01-28
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-01-28
OUR	Sacroiliac Joint Fixation	Orthopedic	Class 2	888.3040	2026-05-21
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2020-01-28
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2022-12-07
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2022-12-07
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2022-12-07
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2022-12-07
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2022-12-07
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2022-12-08
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2020-01-28
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-04-13

Official Correspondent

No official correspondent registered.

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

3D Instrumentation Sdn Bhd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K042598	Zimmer, Inc.	PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES	2004-10-29
K190842	Jiangsu Trauhui Medical Instrument Co., Ltd.	Comus Locking Plate systems	2020-02-03
K130510	Arthrex, Inc.	ARTHREX COMPRESSION PLATES	2013-09-25
K202803	Newclip Technics	Activmotion S DTO	2021-12-16
K062348	Medtronic Neurosurgery	TIMESH SELF DRILLING SCREW	2006-09-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0034-2022	Flower Orthopedics Corporation	2	Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
Z-0014-2014	Synthes USA HQ, Inc.	2	Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016	Ortho Solutions Inc 330 Franklin Tnpk	2	Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014170143. Last updated year: 2026. Please use registration number 3014170143 when referencing this establishment in official correspondence.