Tontarra Medizintechnik GmbH

Tontarra Medizintechnik GmbH specializes in reusable surgical instruments. Their primary device categories include bone punches for orthopedic surgeries, non-illuminating irrigation/aspiration cannulas for managing fluids during procedures, rigid endoscopic stone-retrieval forceps for removing kidney or ureter stones, and soft-tissue surgical hooks for general surgical applications. These instruments are designed for repeated use in clinical settings.

Tontarra Medizintechnik GmbH is headquartered in the United States. The company’s location is relevant for regulatory and compliance purposes, as it influences which regulatory bodies may oversee its devices and where they are distributed.

Tontarra Medizintechnik GmbH’s devices are registered in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for healthcare providers, regulators, and other stakeholders, allowing them to identify and verify the devices in use.

All of Tontarra Medizintechnik GmbH’s listed devices fall under Class I regulatory classification. This classification is typically assigned to low-risk devices that pose minimal potential harm to patients, such as reusable surgical instruments like bone punches, cannulas, forceps, and hooks. Class I devices often require less stringent premarket review but still must comply with general controls and labeling requirements.