NOVABONE PRODUCTS LLC

Novabone Products LLC specializes in the design, manufacturing, and supply of specialized medical devices and orthopedic implants, operating under NAICS 339112, which encompasses surgical and medical instrument manufacturing. The company’s technical expertise lies in precision machining of biocompatible materials, sterile packaging protocols, and adherence to FDA 21 CFR Part 820 quality system regulations. Their capabilities include custom implant fabrication, rapid prototyping for surgical applications, and compliance with ISO 13485 quality management standards. While specific project details are not available, their operational focus suggests deep competency in low-volume, high-precision production for clinical use, with an emphasis on material integrity, dimensional accuracy, and regulatory traceability. Key differentiators include in-house tooling capabilities and a streamlined production workflow optimized for small-batch, mission-critical medical components. No agency relationships can be inferred from the available data, as no contract awards or agency affiliations are documented. Consequently, no patterns of engagement with federal, state, or defense medical procurement entities can be confirmed. The company’s primary industry focus is the medical device manufacturing sector, specifically serving the orthopedic and surgical instrumentation submarket. This includes producing implants, fixation systems, and surgical tools requiring stringent biocompatibility and sterilization controls. Novabone positions itself as a niche supplier for specialized, non-commodity medical hardware, likely serving hospitals, trauma centers, and OEMs requiring custom or limited-run components. Novabone Products LLC is a small, privately held business structured as a 2L entity, indicating a limited organizational hierarchy with likely direct owner involvement in operations. The company is based in Alachua, Florida, and currently holds no formal government certifications such as 8(a), HUBZone, or SDVOSB. Its market presence is localized but aligned with the broader federal medical supply chain, positioning it as a potential Tier 2 or Tier 3 supplier to larger medical device integrators or defense medical logistics networks.