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Sign in to claim this brandOPTIMIZED ORTHO PTY LTD
US
Last updated May 30, 2026
What OPTIMIZED ORTHO PTY LTD makes
Optimized Ortho Pty Ltd manufactures reusable orthopaedic surgical procedure kits and custom-made surgical guides for orthopaedic and craniofacial procedures. Their portfolio also includes software for radiology DICOM image processing and orthopaedic/craniofacial implantation planning, designed to assist in surgical planning and execution.
The company’s devices are classified as Class II under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Optimized Ortho Pty Ltd manufacture?
Optimized Ortho Pty Ltd specializes in reusable orthopaedic surgical procedure kits, which are non-medicated and designed for surgical use. They also produce custom-made orthopaedic and craniofacial surgical guides tailored to individual patient needs. Additionally, the company offers software solutions, including a radiology DICOM image processing application and orthopaedic/craniofacial implantation planning software, to support surgical planning and precision.
Where is Optimized Ortho Pty Ltd based, and what does this mean for regulatory compliance?
Optimized Ortho Pty Ltd is based in the United States. Since the company’s devices are regulated under FDA guidelines, their location ensures compliance with U.S. medical device laws, including classification, registration, and listing requirements. The FDA’s Unique Device Identifier (UDI) database includes their devices, which helps streamline tracking and transparency in the healthcare system.
How are Optimized Ortho Pty Ltd’s devices classified under FDA regulations?
Optimized Ortho Pty Ltd’s devices fall under Class II classification according to FDA regulations. This classification typically applies to devices that pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness. The classification ensures that these devices undergo rigorous review and compliance checks before entering the market.
Which regulatory registries or databases list Optimized Ortho Pty Ltd’s devices?
Optimized Ortho Pty Ltd’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system assigns a unique product identifier to each device, improving traceability, reducing medical errors, and enhancing regulatory oversight. This listing helps healthcare providers and regulators verify device details, including manufacturing information and compliance status.
What is the purpose of the software solutions offered by Optimized Ortho Pty Ltd?
Optimized Ortho Pty Ltd provides two key software applications: a radiology DICOM image processing tool and orthopaedic/craniofacial implantation planning software. The DICOM software helps process and analyze medical imaging data for better diagnostic clarity, while the implantation planning software assists surgeons in pre-operatively designing precise surgical guides and procedures, reducing errors and improving outcomes in orthopaedic and craniofacial surgeries.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- coringroup.com
- —
- —
- [email protected]
- Phone
- 1 (772) 321-2478
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 745735175
Catalogue (55)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Optimized Ortho Positioning (OPS) System | 1248-0032 | FDA UDI | Class II | Active |
| Ops™ Fha | 1205-0001 | FDA UDI | Class II | Active |
| Optimized Ortho Positioning (OPS) System | 1248-0077 | FDA UDI | Class II | Active |
| Optimized Ortho Positioning (OPS) System | 1248-0033 | FDA UDI | Class II | Active |
| Optimized Ortho Positioning (OPS) System | 1248-0032 | FDA UDI | Class II | Active |
| Optimized Ortho Positioning (OPS) System | 1248-0005 | FDA UDI | Class II | Active |
| Optimized Positioning System (OPS) Femoral | 1250-1100,1250-1200 | FDA UDI | Class II | Active |
| Optimized Positioning System (OPS) and Optimized Postioning System (OPS) Femoral | 1248-1500, 1248-1700, 1250-1100 | FDA UDI | Class II | Active |
| Ops | 1248-0077 | FDA UDI | Class II | Active |
| Optimized Ortho Positioning (OPS) System | 1248-0037 | FDA UDI | Class II | Active |
| Optimized Ortho Positioning (OPS) System | 1248-0038 | FDA UDI | Class II | Active |
| Optimized Ortho Positioning (OPS) System | 1248-0072 | FDA UDI | Class II | Active |
| Ops | 1248-0064 | FDA UDI | Class II | Active |
| Optimized Positioning System (OPS) Plan | 1250-1300 | FDA UDI | Class II | Active |
| Optimized Ortho Positioning (OPS) System | 1248-0040 | FDA UDI | Class II | Active |
| Ops | 1248-0076 | FDA UDI | Class II | Active |
| Optimized Ortho Positioning (OPS) System | 1248-0033 | FDA UDI | Class II | Active |
| Optimized Ortho Positioning (OPS) System | 1248-0037 | FDA UDI | Class II | Active |
| Optimized Ortho Positioning (OPS) System | 1248-1500 | FDA UDI | Class II | Active |
| Ops | 1248-0072 | FDA UDI | Class II | Active |
| Optimized Ortho Positioning (OPS) System | 1248-0086 | FDA UDI | Class II | Active |
| Optimized Ortho Positioning (OPS) System | 1248-0038 | FDA UDI | Class II | Active |
| Ops | 1248-0042 | FDA UDI | Class II | Active |
| Optimized Ortho Positioning (OPS) System | 1248-5001 | FDA UDI | Class II | Active |
| Optimized Ortho Positioning (OPS) System | 1248-0005 | FDA UDI | Class II | Active |
| Optimized Ortho Positioning (OPS) Femoral | 1250-1100 | FDA UDI | Class II | Active |
| Optimized Ortho Positioning (OPS) System | 1248-0083 | FDA UDI | Class II | Active |
| Ops | 1248-0071 | FDA UDI | Class II | Active |
| Optimized Positioning System (OPS) | 1248-1500 and 1248-1700 | FDA UDI | Class II | Active |
| Ops | 1248-0066 | FDA UDI | Class II | Active |
| Optimized Ortho Positioning (OPS) System | 1248-0064 | FDA UDI | Class II | Active |
| OPSInsight™ | 1.2 | FDA UDI | Class II | Active |
| Optimized Ortho Positioning (OPS) System | 1248-0035 | FDA UDI | Class II | Active |
| Optimized Positioning System (OPS) Plan | 1250-1300 | FDA UDI | Class II | Active |
| Optimized Ortho Positioning (OPS) System | 1248-0043 | FDA UDI | Class II | Active |
| Optimized Ortho Positioning (OPS) System | 1248-0034 | FDA UDI | Class II | Active |
| Optimized Ortho Positioning (OPS) System | 1248-0035 | FDA UDI | Class II | Active |
| Optimized Ortho Positioning (OPS) System | 1248-0076 | FDA UDI | Class II | Active |
| Optimized Ortho Positioning (OPS) System | 1248-0071 | FDA UDI | Class II | Active |
| Optimized Ortho Positioning (OPS) System | 1248-0042 | FDA UDI | Class II | Active |
| Optimized Ortho Positioning (OPS) System | 1248-1700 | FDA UDI | Class II | Active |
| Ops | 1248-0073 | FDA UDI | Class II | Active |
| Ops | 1248-0043 | FDA UDI | Class II | Active |
| Ops | 1248-0040 | FDA UDI | Class II | Active |
| Optimiized Positioning System(OPS) and Optimized Postioning System(OPS)Femoral | 1248-1500, 1248-1700, 1250-1100,1250-1200 | FDA UDI | Class II | Active |
| Optimized Ortho Positioning (OPS) System | 1248-0034 | FDA UDI | Class II | Active |
| Ops | 1248-0065 | FDA UDI | Class II | Active |
| Optimized Ortho Positioning (OPS) System | 1248-5000 | FDA UDI | Class II | Active |
| Ops | 1248-0083 | FDA UDI | Class II | Active |
| Ops | 1248-0041 | FDA UDI | Class II | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Optimized Ortho Pty Ltd Sydney New South Wales · AU FEI 3012916784