ISO 13485 Certified Orthopedic Implant OEM/ODM Manufacturer

Manufacturing Leadership

Over 25 Years of Precision Engineering & Global Healthcare OEM Partnerships

Orthovana Medical Co., Ltd was established in 1997. For over 25 years, we have specialized in the research, engineering, multi-axis machining, quality assurance, and global export of medical-grade orthopedic implants and matching surgical instrument sets.

Our dedicated R&D department brings together over 20 senior biomedical engineers and technical consultants. Many of our engineering leaders bring extensive background in technical co-development and OEM/ODM manufacturing projects alongside top-tier global medical device brands.

Every system manufactured in our facilities—ranging from titanium trauma locking compression plates (LCP) and cannulated screws to spinal pedicle screw systems, PEEK interbody fusion cages, and low-profile maxillofacial fixation systems—is optimized for real surgical workflows, anatomical fit, and biological stability.

Key Manufacturing Standards

  • ✓ Raw Materials: ASTM F136 Ti-6Al-4V ELI titanium alloy, ASTM F67 commercially pure titanium, and implant-grade PEEK with radiopaque markers.
  • ✓ Quality System: Certified to ISO 13485 quality management since 2003 with full batch-level raw material and processing traceability.
  • ✓ Regulatory Ready: Technical files, IFUs, registration dossiers, and lot documentation support local registration for international distributors.
State-of-the-Art Infrastructure

Advanced Manufacturing & Testing Capabilities

Built on multi-axis CNC technology, rigorous physical-chemical mechanical testing labs, and ISO 14644 cleanroom environments.

High-Precision Machining

Equipped with Germany DMG Mori 5-axis machining centers, USA HAAS 5-axis machining centers, and Japanese Citizen 9-axis turning-milling centers for micron-level tolerance accuracy.

Complete In-House Testing Lab

On-site physical, chemical, and mechanical testing laboratories perform static, dynamic, and fatigue testing according to ASTM and ISO testing standards.

ISO 13485 & CE Certified

Continuous adherence to medical device quality management standards since 2003, verified with TÜV CE0123 certification for international tender compliance.

Class 10,000 ISO Cleanrooms

Sterile and controlled packaging environment complying with ISO 14644 cleanroom standards to maintain low particulate levels and non-pyrogenic product conditions.

Development History

Our Growth & Manufacturing Milestones

Over 25 years of steady progression from a local specialist manufacturer into a global OEM orthopedic partner.

1997
Orthovana Medical Co., Ltd was founded, establishing core manufacturing operations focused on high-precision trauma bone plates and bone screws.
2003
Achieved initial ISO 13485 quality management certification and officially expanded international OEM & private label manufacturing capabilities.
2008
Expanded product families from trauma plates to comprehensive spinal fixation systems and CMF reconstruction systems for international markets.
2014
Upgraded quality audit processes and renewed TÜV CE (CE0123) certification, reinforcing product conformity to European and global medical regulations.
2021
Relocated to a modern 20,000 m² state-of-the-art facility equipped with expanded 5-axis CNC multi-axis centers and extended cleanroom capacity.
Proven Experience

Global Healthcare Reach

30+
Countries Registered
$10M+
Annual Export Volume
25+
Years Industry Expertise
Global Customer Support

Partner with Orthovana Medical Co., Ltd

Our sales and engineering teams are ready to support your market tender requests, custom OEM manufacturing projects, and product catalog inquiries.

Address: No. 22 Changyang Rd., Wujin Economic Development Zone, 213149 Changzhou, Jiangsu, China

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