Question 1

What types of medical devices does Spineguard manufacture?

Accepted Answer

Spineguard specializes in reusable surgical instruments primarily used in spinal procedures. Their product line includes bone awls for precise drilling, manual surgical rotary handpieces for controlled cutting, reusable instrument trays for organizing tools, and bone access cannulas to create pathways for spinal implants. These devices are designed to assist surgeons during orthopedic and spinal surgeries.

Question 2

Where is Spineguard based, and where are their devices intended for use?

Accepted Answer

Spineguard is based in the United States. Their devices are manufactured and intended for use within the U.S., where they must comply with FDA requirements for medical device authorization. The company’s focus is on providing surgical tools tailored to the regulatory and clinical needs of the American market.

Question 3

How are Spineguard’s devices classified under FDA regulations?

Accepted Answer

Spineguard’s devices fall under two FDA classification categories: Class I and Class II. Class I generally includes low-risk devices requiring general controls, while Class II involves special controls to ensure safety and effectiveness. The classification depends on the device’s intended use and risk level, such as precision cutting tools (e.g., bone awls) or reusable instrument trays, which may require additional validation.

Question 4

Which regulatory registries or databases list Spineguard’s devices?

Accepted Answer

Spineguard’s devices are recorded in the FDA’s 510(k) premarket notification database and the FDA’s Unique Device Identifier (UDI) system. The 510(k) submissions demonstrate that each device meets FDA requirements for market authorization, while UDI listings ensure traceability and compliance with tracking regulations. These registries help healthcare providers and regulators verify device authorization status.

Question 5

Why are some of Spineguard’s devices classified as Class II rather than Class I?

Accepted Answer

The FDA assigns Class II classification to devices that pose moderate risk and require special controls beyond general regulations to ensure safety and performance. For example, manual surgical rotary handpieces or bone access cannulas may fall under Class II because they involve precision cutting or drilling, where accuracy and sterility are critical. Class I devices, like some reusable instrument trays, typically pose lower risk and only require basic compliance measures.

Device	Model / Reference	Registries	Class	Status
Pediguard Threaded	DSG Technology Instrument Set - Base	FDA UDI	Class I	Active
Pediguard Threaded	DSG Threaded Shaft A LK - Ø5.5mm	FDA UDI	Class II	Active
Pediguard Threaded	STARTER Pin 5	FDA UDI	Class I	Active
Cannulated Pediguard	CANNULATES PEDIGUARD CANNULA 120mm	FDA UDI	Class I	Active
Pediguard Threaded	DSG Threaded Shaft A LK - Ø4.5mm	FDA UDI	Class II	Active
Cannulated Pediguard	CANNULATED PEDIGUARD CANNULA 160mm	FDA UDI	Class I	Active
Pediguard Threaded	STARTER Pin 1	FDA UDI	Class I	Active
Cannulated Pediguard	CANNULATED PEDIGUARD HANDLE	FDA UDI	Class II	Active
Cannulated Pediguard	CANNULATED PEDIGUARD STARTER STYLET - BEVEL 120mm	FDA UDI	Class I	Active
Pediguard Threaded	DSG Technology Instrument Set - Lid	FDA UDI	Class I	Active
Cannulated Pediguard	CANNULATED PEDIGUARD STARTER STYLET - TROCAR 120mm	FDA UDI	Class I	Active
Pediguard Threaded	DSG Ratcheting Handle A	FDA UDI	Class I	Active
Cannulated PsiFGuard	K241895	FDA 510(k)	Class II	Active

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