Lord’s Mark Industries has secured US Food and Drug Administration registrations for 153 orthosurgical products, placing the company among a limited group of Indian medical device manufacturers with listings of this scale. The registrations cover products manufactured at the company’s facilities in India and are intended for regulated international markets.
The company said all listed products are produced within its manufacturing ecosystem, which operates under internationally benchmarked protocols. According to Lord’s Mark Industries, the facilities follow structured quality management systems, validated processes, and end-to-end traceability aligned with US FDA requirements. The registrations mark an expansion of the company’s regulatory reach at a time when demand for compliant medical devices is increasing across global healthcare systems.
The portfolio includes a wide range of orthosurgical and rehabilitation products, spanning braces, supports, compression wear, post-surgical aids, and hygiene-related medical consumables. The breadth of the listings reflects the company’s manufacturing capacity across multiple product categories rather than a single therapeutic segment.
Manufacturing base and product range detailed
The US FDA-listed products include orthopaedic braces, spinal and cervical supports, knee and ankle braces, compression stockings, hernia belts, elastic knee supports, cervical collars, chin support belts, disinfectant and cleansing wipes, tennis elbow supports, adhesive bandages, abdominal supports, travel neck pillows, and post-surgical rehabilitation items .
Lord’s Mark Industries said these products are manufactured at its Silvassa facility, which has been developed to meet regulatory expectations for export-oriented medical devices. The company described its production framework as being built around compliance controls rather than retrofitted for regulatory approvals.
The registrations allow the company to supply into markets that require US FDA-listed products, either directly or through distribution partners. Industry analysts note that such listings are often used as a reference point by regulators in other regions, particularly in Latin America and parts of the Middle East.
Company outlines regulatory and market implications
Commenting on the development, Sachidanand Upadhyay, Managing Director of Lord’s Mark Industries, said: “This milestone goes beyond regulatory recognition. It reinforces our belief that world-class medical devices can be designed, manufactured, and regulated from India at global scale. Being one of the company to secure US FDA recognition for 153 orthosurgical products reflects the strength of our Silvassa manufacturing platform, our regulatory discipline, and our long-term vision to position India as a trusted source of globally compliant healthcare solutions” .