ACERA SURGICAL INC.

ACERA SURGICAL INC. specializes in the design, manufacture, and supply of precision surgical instruments and medical implants, serving critical needs within the veteran healthcare ecosystem. Their technical expertise lies in the production of Class II medical devices compliant with FDA regulations and ISO 13485 quality standards, with a focus on reusable and disposable surgical tools, implantable devices, and related clinical accessories. The company demonstrates deep competency in regulatory documentation, sterilization protocols, and supply chain traceability for high-risk surgical applications, ensuring devices meet stringent clinical and safety requirements in operating room environments. Their ability to deliver custom-engineered solutions under tight regulatory frameworks distinguishes them as a reliable partner for mission-critical medical hardware. The Department of Veterans Affairs is their primary and consistent federal partner, with multiple engagements spanning surgical instrument manufacturing and implantable appliance production. These contracts reflect a sustained relationship built on reliability in delivering specialized surgical hardware tailored to veteran-specific clinical needs, including orthopedic, neurosurgical, and trauma care applications. ACERA SURGICAL INC. has established itself as a trusted vendor within VA’s medical supply chain, supporting procurement for VA medical centers and VA-affiliated surgical facilities. The contractor’s industry focus centers on NAICS 339112 and 339113, which encompass the precision manufacturing of surgical instruments and medical implants—areas requiring rigorous quality control, material science expertise, and adherence to biocompatibility standards. They position themselves as a niche supplier to government healthcare systems requiring FDA-registered, domestically produced surgical devices with full documentation for 510(k) or PMA pathways. ACERA SURGICAL INC. is a small business structured as a 2L entity, headquartered in St. Louis, Missouri. While currently holding no formal government certifications, their consistent performance with the VA underscores their operational reliability and alignment with federal procurement standards for medical device manufacturing.