Remak Ortho Pvt Ltd is a premier manufacturer and exporter of ISO 13485:2016 and CE-certified orthopedic implants. We specialize in providing medical device importers, hospital supply networks, and regional distributors worldwide with direct factory access to high-precision spinal systems, trauma fixation plates, intramedullary nails, PEEK cages, and surgical instruments.
Every product batch is manufactured under strict ISO 13485:2016 and GMP standards. Full technical documentation, Material Test Reports (MTR), and Certificate of Analysis (CoA) are available for international regulatory submissions.
We strictly utilize medical-grade raw materials sourced from certified global suppliers: Titanium Grade 5 (Ti-6Al-4V ELI), Stainless Steel 316L/LVM, and implant-grade PEEK for long-term clinical safety and durability.
From private labeling, specialized packaging, and laser marking to custom implant sizing and surgical instrument set development, our engineering team handles tailored OEM requirements efficiently.
Submit your product SKU, material grade, sizing specifications, or OEM customization drawings.
Receive a comprehensive B2B quotation including volume pricing, FOB/CIF terms, and lead times.
Review samples, technical datasheets, and regulatory compliance documents before mass production.
Secure export-grade packaging with air/sea delivery trackable to your target seaport or destination airport.
We assist our overseas partners with complete regulatory Dossier files (STED format), Certificate of Free Sale (CFS), ISO 13485 accreditation, CE conformity certificates, and sterilization validation reports. Our experienced regulatory affairs division ensures fast-track registration in countries across Latin America, Southeast Asia, the Middle East, Africa, and Eastern Europe.
Need technical datasheets, bulk price lists, or OEM sample kits? Click below to communicate directly with our dedicated global export representatives.
Send an Inquiry