Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012755988

FEI Number

3012755988

Entity Name

Ortho Solutions Sdn Bhd

City/State/Country

Prai, Penang Pulau Pinang, MY

Establishment Address

2821, Tingkat Perusahaan 5A, Prai Industrial Estate, Prai, Penang Pulau Pinang 13600, MY

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Ortho Solutions Sdn Bhd (Owner Number: 10079077)

Owner / Operator Contact Address

89 South Commerce Way, Suite 990, Bethlehem, PA 18017, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Guide, Surgical, Instrument INSTRUMENT, MANUAL, SURGICAL, GENERAL USE FORCEPS Paragon 28 External Ring Fixation System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2020-11-17
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2024-03-05
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-03-05
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2020-12-22
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-11-21
GFG	Bit, Surgical	General, Plastic Surgery	Class 1	878.4820	2020-11-17
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2020-11-17
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2020-11-19
HWW	Countersink	Orthopedic	Class 1	888.4540	2020-11-19
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2026-01-07
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2024-03-22
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2023-03-02
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-05-28
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-05-28
HTO	Reamer	Orthopedic	Class 1	888.4540	2023-05-02
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2020-11-18
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2024-11-11
KRO	Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3510	2023-12-21
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2024-03-22
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-03-22
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2024-03-22
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2021-10-21
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2024-11-12
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2023-06-07
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-03-22
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2024-03-22
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2024-10-09
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-10-09
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2024-10-09
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2023-06-07
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2023-06-07
PAO	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented	Orthopedic	Class 2	888.3660	2023-06-07
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-11-25
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2020-11-25
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-06-30
LRZ	Screwdriver, Surgical	General, Plastic Surgery	Class 1	878.4800	2023-05-02
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-11-18
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2020-11-18
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2025-03-18
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2020-11-18

Official Correspondent

Lisa Boyle

US Agent Details

Tania Shammo Business: Exalta-PNG Email: tshammo@exalta.com Phone: (262) 2886450

Related Public Records

Same Entity

Ortho Solutions 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.

Similar Registrations

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9610622	STRYKER TRAUMA GMBH	SCHOENKIRCHEN Schleswig-Holstein, DE
3036795921	KLS MARTIN SE & CO. KG	Fridingen Baden-Wurttemberg, DE
1020279	SMITH & NEPHEW, INC.	MEMPHIS, TN, US
3004215117	MILLENNIUM SURGICAL CORP	Schaumburg, IL, US
3010041499	Tegra Medical	Hernando, MS, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012755988. Last updated year: 2026. Please use registration number 3012755988 when referencing this establishment in official correspondence.