Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008572101

FEI Number

3008572101

Entity Name

Symmetry Medical Malaysia Sdn Bhd (758243-M)

City/State/Country

Bayan Lepas Pulau Pinang, MY

Establishment Address

Plot 80C Kawasan Perusahaan Bayan Lepas, Lintang Bayan Lepas 7, Bayan Lepas Pulau Pinang 11900, MY

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Symmetry Medical Malaysia Sdn Bhd (758243-M) (Owner Number: 10033686)

Owner / Operator Contact Address

Plot 80C Kawasan Perusahaan Bayan Lepas, Lintang Bayan Lepas 7, Bayan Lepas, MY-07 11900, MY

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Flashpak Case Acetabular Reamer INSTRUMENTS FOR DISTRIBUTION IN THE US Microloc Instruments EMPERION ATTUNE A-P CHAMFER BLOCK PINN CUP IMPACTOR TIP PINN POLY IMPACTOR ECHELON, ANTHOLOGY

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2016-11-21
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2017-02-23
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2014-01-28
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2025-03-17
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2010-09-17
MAY	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish	Orthopedic	Class 2	888.3353	2014-01-28
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2014-01-28
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2014-01-28
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2014-01-28
MBL	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous	Orthopedic	Class 2	888.3358	2014-01-28
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2013-09-17
HTZ	Instrument, Cutting, Orthopedic	General, Plastic Surgery	Class 1	878.4800	2023-02-03
HWA	Impactor	Orthopedic	Class 1	888.4540	2025-09-19
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2014-01-28
KTZ	Caliper	Orthopedic	Class 1	888.4150	2014-01-28
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2014-01-28
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2014-01-28
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2016-08-15
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2014-11-26
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2014-11-26
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2014-02-07
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2014-02-07

Official Correspondent

Theng Fong Chin

US Agent Details

Michael E Parrish Business: Tecomet, Inc. Email: mike.parrish@tecomet.com Phone: (574) 3712237

Related Public Records

Same Entity

Symmetry Medical Malaysia Sdn Bhd (758243-M)

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
K860442	Howmedica Corp.	PRECISION HIP SYSTEM PROXIMAL FEMORAL SPACER #6259	1986-05-06
K973124	Sulzer Orthopedics, Inc.	APR POROUS HA HIP SYSTEM	1997-11-03
K062348	Medtronic Neurosurgery	TIMESH SELF DRILLING SCREW	2006-09-08
K063244	Arc Surgical, LLC	ARC SURGICAL BONE REDUCTION SCREW	2006-12-27
K972722	Orthopedic Designs, Inc.	ULTIMATE COMPRESSION SCREW SYSTEM	1998-01-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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.
Z-0043-2018	MicroPort Orthopedics Inc.	2	MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008572101. Last updated year: 2026. Please use registration number 3008572101 when referencing this establishment in official correspondence.