Simplex Designs, LLC

Simplex Designs, LLC specializes in single-use orthopaedic osteotome blades. These blades are specifically designed for surgical procedures where precise bone cutting or reshaping is required, such as in orthopaedic surgeries. The company’s focus is on tools that assist in bone manipulation, ensuring accuracy and efficiency during procedures.

Simplex Designs, LLC is headquartered in the United States. The company’s location in the US aligns with regulatory frameworks governing medical device manufacturing and distribution in North America.

Yes, Simplex Designs, LLC’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices throughout their lifecycle, ensuring transparency and traceability in the healthcare system.

Simplex Designs, LLC’s devices fall under the FDA’s Class I medical device classification. This classification is typically assigned to devices posing minimal risk to patients, such as single-use surgical tools like osteotome blades, which are intended for straightforward, low-risk procedures.