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US FDA Inspected & ISO 13485 Certified Implant Manufacturer

GPC Medical USA Precision Orthopedic Implant Manufacturing Facility

GPC Medical USA, Inc. is a premier orthopedic implant manufacturing and supply company headquartered in Dallas, Texas. Established in 2016, our US division bridges state-of-the-art medical engineering with global healthcare distribution, supplying hospitals, trauma centers, and medical supply partners across North America, Latin America, Europe, Asia, and the Middle East.

Our global manufacturing operations are anchored by our dedicated facility in New Delhi, India, which holds the distinction of being the first Indian orthopedic manufacturing plant inspected and cleared by the US FDA (since 2010). With over a decade of continuous regulatory compliance and international quality audits, we provide healthcare systems worldwide with affordable, surgeon-tested trauma and spine solutions without compromising precision or safety.

Our Core Expertise & Manufacturing Excellence

Driven by our mission of "Delivering Accessible & Uncompromised Trauma Care Worldwide", GPC Medical USA leverages cutting-edge manufacturing technology to maintain absolute consistency across all product lines.

Swiss CNC Machining
Equipped with 3, 4, 5 & 9-axis CNC machines and Swiss whirling head technology, producing single-setup complex bone screws and locking plates with ultra-precise tolerances.
US FDA & ISO Certified
Fully compliant with ISO 13485 quality management system standards and regular US FDA inspection protocols, ensuring full material traceability.
Biocompatible Materials
Exclusively utilizing premium medical-grade Titanium Alloy (Ti-6Al-4V ELI) and Stainless Steel (316L) conforming to ASTM F136 and ASTM F138 specifications.
Global B2B Supply Chain
Direct export, OEM/ODM capabilities, and strategic warehousing in Dallas, TX, facilitating rapid dispatch and flexible order quantities for importers.

High-Precision Manufacturing Technology

Our investment in advanced Swiss whirling technology allows complete unit fabrication on a single workstation. This significantly reduces manufacturing overheads, eliminates dimensional discrepancies, and strengthens our ability to supply world-class orthopedic implants at factory-direct B2B prices.

Quality Assurance & Manufacturing Capabilities

9-Axis Swiss Automatic Lathes
Multi-Axis Thread Whirling Units
100% CMM Dimensional Verification
Class 10,000 Cleanroom Packaging
Complete Heat Treatment & Anodizing
Full Lot-Level Raw Material Traceability

Comprehensive Product Portfolio for International Importers

GPC Medical USA stocks over 200 orthopedic SKUs, supporting hospital procurement requirements across multiple trauma and spinal surgical procedures:

  • fixLOCK Locking Plating System: Anatomically contoured 3.5mm and 5.0mm titanium and stainless locking plates for small and large fragment fractures.
  • intraHEAL Intramedullary Nailing System: Interlocking tibial, femoral, and cephalic hip stabilizing nails for advanced fracture fixation.
  • spineHEAL Pedicle Screw System: Monoaxial, polyaxial, and reduction pedicle screws with cross-connectors and titanium spinal rods.
  • Distal Radius System: Variable-angle 2.4mm column plates engineered for complex intra-articular wrist fractures.

Ready to Expand Your Orthopedic Product Portfolio?

Partner with GPC Medical USA to supply US FDA-inspected, ISO-certified Spine and Trauma implants in your market with competitive B2B margins.

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ISO 13485 Certified Quality
Competitive Factory B2B Pricing
Fast Global Freight Logistics
US FDA Inspected Facility