OEM Partnerships
Your Partner in Biologic Innovation
With decades of expertise in tissue processing, product development, and regulatory compliance, Xtant Medical serves as a trusted OEM partner for companies seeking biologic solutions backed by science, safety, and scalability. Our vertically integrated operations ensure full control, from donor recovery through distribution we deliver consistent, high-quality allografts and advanced biologic graft options.
Comprehensive Capabilities
Our ISO 13485:2016 + MDSAP certified facility provides end-to-end manufacturing capabilities, supporting a wide range of custom and private-label solutions. Every partnership benefits from our patented processing technologies and rigorous quality standards designed to preserve the natural properties of human tissue.
Our capabilities include:
- Tissue Processing & Formulation – Aseptic techniques in ISO 14644 Class 5 cleanrooms ensure product purity and consistency.
- Product Development – Collaborative engineering and design support for new or existing biologic product lines.
- Packaging & Labeling – Flexible private-label options tailored to your brand and regulatory requirements.
- Testing & Validation – CLIA-accredited laboratory testing and sterility assurance at SAL 10⁻⁶.
- Regulatory Support – FDA HCT/P and Device Registration, ISO and AATB accreditations, and full traceability documentation.
Quality You Can Trust
Xtant’s quality management system meets the highest global standards for safety and performance. Our proprietary BacteRinse ™ process and validated sterilization methods maintain tissue integrity while ensuring bioburden reduction and clinical reliability.
Honoring the Gift
Every partnership reflects our mission — to honor the gift of donation by transforming it into life-changing medical solutions. We uphold this commitment through ethical sourcing, transparent practices, and an unwavering dedication to patient safety.
Let’s Partner Together
From concept to commercialization, Xtant Medical partners with OEM clients to bring biologic innovation to market with precision, compliance, and confidence.