Question 1

What types of medical devices does 3D-Side manufacture?

Accepted Answer

3D-Side specializes in surgical imaging and navigation technology. Their primary product, the Archer PSI System, is designed to assist in precise imaging and navigation during orthopedic and spinal surgeries. The system is engineered to enhance surgical accuracy and efficiency in these specialized procedures.

Question 2

Where is 3D-Side based?

Accepted Answer

3D-Side is headquartered in the United States. The company’s location in the US aligns with its focus on developing and distributing medical devices that comply with regulatory standards in North America.

Question 3

How are 3D-Side’s devices classified under FDA regulations?

Accepted Answer

The Archer PSI System, 3D-Side’s key product, is classified as a Class II device by the FDA. This classification is based on its intended use for surgical imaging and navigation, which carries moderate risk compared to Class I devices but requires additional controls to ensure safety and effectiveness.

Question 4

Which regulatory registries or clearance processes does 3D-Side’s Archer PSI System go through?

Accepted Answer

The Archer PSI System is listed via the FDA’s 510(k) clearance process. This pathway demonstrates that the device meets regulatory requirements by showing substantial equivalence to a legally marketed predicate device, ensuring it complies with FDA standards for safety and performance.

3D-Side

Catalogue8

3D-Cut Ar-13100PSG Ref AR-13100PSG

3D-Cut 02-Psi-T Ref 02-PSI-T

3D-Cut Ar-13402PSG Ref AR-13402PSG

3D-Cut Ar-13700PSG Ref AR-13700PSG

3D-Cut Ar-13200PSG Ref AR-13200PSG

3D-Cut Ar-13400PSG Ref AR-13400PSG

3D-Cut Ar-13401PSG Ref AR-13401PSG

Archer PSI System Ref K243509

What 3D-Side makes

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