Spierings Orthopaedics B.V.

Spierings Orthopaedics B.V. specializes in orthopaedic instruments, primarily for surgical use. Their product range includes single-use items like osteotome blades and handles, as well as reusable tools such as surgical torque wrenches and manual bone mills. They also produce components for acetabular cup extraction systems, including polymer and SST heads, starter and finisher blades, and connectors. Additionally, they offer sterilization/disinfection containers designed for reusable surgical devices.

The company is based in the United States, though the exact location is not specified. Their focus is on manufacturing orthopaedic instruments intended for use in surgical procedures within the U.S. regulatory environment.

Spierings Orthopaedics B.V.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and compliance tracking for medical devices authorized in the United States.

All of Spierings Orthopaedics B.V.’s devices fall under Class I classification in the FDA’s regulatory framework. This classification applies to devices posing the lowest risk, typically those with minimal potential harm when used as intended. The classification is determined based on factors like the device’s purpose, design, and potential risks, ensuring appropriate oversight while maintaining accessibility for surgical use.