Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008840738

FEI Number

3008840738

Entity Name

HAMAGAWA INDUSTRIAL (M) SDN BHD

City/State/Country

Sungai Petani Kedah, MY

Establishment Address

Lot 26, Jalan 8, Bakar Arang Industrial Estate, Sungai Petani Kedah 08000, MY

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

HAMAGAWA INDUSTRIAL (M) SDN BHD (Owner Number: 10047158)

Owner / Operator Contact Address

Lot 26, Jalan 8, Bakar Arang Industrial Estate, Sungai Petani, MY-02 08000, MY

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Trial Liner, 10, 36mm Head, Size 60 62mm Screw Inserter Trial Femoral Head, 28mm, S Kratos Trial Neck, H/O (Lateralized) Trial Femoral Head, 36mm, XL Trial Acetabular Cup, Size 52mm Straight Cup Inserter Quick Release Box Osteotome Trial Acetabular Cup, Size 60mm Large Reamer Handle Trial Acetabular Cup, Size 56mm Tray, Bonded Stem Trial Liner, Neutral, 36mm Head, Size 52 54mm Trial Acetabular Cup, Size 68mm Trial Femoral Head, 32mm, L Screw Driver Handle Trial Femoral Head, 36mm, M Trial Liner, 10, 28mm Head, Size 52 54mm Broach Handle power adapter Trial Femoral Head, 32mm, S Trial Femoral Head, 36mm, S Trial Liner, 10, 36mm Head, Size 56 58mm Calcar Reamer, Large Trial Liner, Neutral, 36mm Head, Size 60 68mm Drill Depth Gauge Stem Impactor Trial Liner, Neutral, 28mm Head, Size 44 46mm Straight Broach Handle Alignment Guide Trial Acetabular Cup, Size 54mm Trial Acetabular Cup, Size 64mm Trial Femoral Head, 28mm, L Tapered Pin Reamer Trial Femoral Head, 32mm, M Trial Acetabular Cup, Size 62mm Quick Release Head Impactor Trial Acetabular Cup, Size 48mm Trial Liner, Neutral, 32mm Head, Size 48 50mm Trial Liner, 10, 32mm Head, Size 52 54mm Trial Liner, Neutral, 32mm Head, Size 52 54mm Trial Acetabular Cup, Size 44mm Stem Positioner Trial Liner, 10, 32mm Head, Size 60 68mm Osteotomy Guide Trial Liner, 10, 36mm Head, Size 52 54mm Trial Acetabular Cup, Size 50mm Trial Femoral Head, 36mm, L IM Drill Trial Liner, 10, 28mm Head, Size 44 46mm Trial Femoral Head, 32mm, XL Drill Guide Liner Impactor, 28mm Trial Femoral Head, 28mm, M Trial Liner, Neutral, 36mm Head, Size 56 58mm Reamer Shaft Trial Acetabular Cup, Size 58mm Trial Liner, 10, 28mm Head, Size 48 50mm Tray, Tryon Acetabular System Liner Impactor, 32mm Quick Connect Drill Shaft Kratos Trial Neck, Standard Trial Liner, 10, 32mm Head, Size 48 50mm Trial Liner, Neutral, 28mm Head, Size 48 50mm Trial Liner, 10, 32mm Head, Size 56 58mm 3.5 Hex Screw Driver Shaft Trial Acetabular Cup, Size 66mm Trial Liner, Neutral, 32mm Head, Size 60 68mm Trial Liner, Neutral, 28mm Head, Size 52 54mm Quick Release Stem Impactor Liner Impactor, 36mm Tryon 2 Tray Stepped Entry Reamer Trial Liner, Neutral, 32mm Head, Size 56 58mm Trial Acetabular Cup, Size 46mm Dymaxeon Spine System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2014-07-08

Official Correspondent

No official correspondent registered.

US Agent Details

Jeremy Tincher Email: jeremy@signatureortho.us Phone: (901) 3312747

Related Public Records

Same Entity

HAMAGAWA INDUSTRIAL (M) SDN BHD

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007	Smith & Nephew Inc	1	Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06	Stryker Howmedica Osteonics Corp.	1	Allocraft TLIF Bone Inserter.
Z-0011-2007	Smith & Nephew Inc	1	Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105
Z-0013-2011	Depuy Orthopaedics, Inc.	1	Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143 Catalog Number: 2570-00-000 The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty.

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3021574846	3D LOGICS LLC	Hillsboro, OR, US
3030089866	ORTOLOG MEDIKAL SANAYI VE TICARET A.S.	Yenimahalle Ankara, TR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008840738. Last updated year: 2026. Please use registration number 3008840738 when referencing this establishment in official correspondence.