Question 1

What types of medical devices does Advanced Research Medical LLC manufacture?

Accepted Answer

Advanced Research Medical LLC specializes in spinal and orthopaedic devices. Their portfolio includes metallic spinal interbody fusion cages for lumbar procedures, sacroiliac joint fixation implants, and reusable surgical instruments like curettes, instrument trays, and orthopaedic positioning tools. They also produce a neurosurgical microscope for precision surgical applications, along with orthopaedic implantation sleeves and specialized instrument handles.

Question 2

Where is Advanced Research Medical LLC based, and how does that affect its regulatory oversight?

Accepted Answer

Advanced Research Medical LLC is based in the United States, which means its devices fall under the jurisdiction of the FDA (U.S. Food and Drug Administration). Since the company operates within the U.S., its products are authorised through FDA pathways like the 510(k) premarket notification process and are required to comply with U.S. regulatory standards, including UDI (Unique Device Identification) requirements.

Question 3

Which regulatory registries or databases list Advanced Research Medical LLC’s devices?

Accepted Answer

Advanced Research Medical LLC’s devices are listed in the FDA’s 510(k) premarket notification database, as well as the FDA’s Unique Device Identification (UDI) system. These registries ensure transparency and traceability of authorised medical devices under U.S. regulatory oversight.

Question 4

How are Advanced Research Medical LLC’s devices classified under FDA regulations?

Accepted Answer

Advanced Research Medical LLC’s devices are primarily classified as Class I or Class II under FDA regulations. Class I devices generally pose the lowest risk and may be exempt from some regulatory controls, while Class II devices require special controls to ensure their safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the body area it interacts with, such as spinal or joint applications.

Question 5

Why do some of Advanced Research Medical LLC’s devices require 510(k) clearance?

Accepted Answer

The 510(k) pathway is used for devices that are not exempt from premarket notification requirements. Since Advanced Research Medical LLC’s devices—such as spinal fusion cages, fixation implants, and reusable surgical instruments—pose moderate risks (e.g., potential complications from improper placement or material interactions), they must demonstrate substantial equivalence to a legally marketed predicate device to ensure they meet FDA safety and performance standards before being authorised for commercial distribution.

Device	Model / Reference	Registries	Class	Status
Advanced Research Medical Trident SI Screw System	03-50-6	FDA UDI	Class II	Active
Advanced Research Medical Trident SI Screw System	03-50-13	FDA UDI	Class II	Active
Advanced Research Medical Trident SI Screw System	03-65-6	FDA UDI	Class II	Active
Advanced Research Medical Trident SI Screw System	03-04	FDA UDI	Class II	Active
Lumbar Interbody Fusion System (OLLIF)	01-3312	FDA UDI	Class II	Active
Lumbar Interbody Fusion System (OLLIF)	01-C4	FDA UDI	Class II	Active
Advanced Research Medical Trident SI Screw System	03-01	FDA UDI	Class II	Active
Lumbar Interbody Fusion System (OLLIF)	01-14-6	FDA UDI	Class II	Active
Lumbar Interbody Fusion System (OLLIF)	01-2708	FDA UDI	Class II	Active
Lumbar Interbody Fusion System (OLLIF)	01-00-1	FDA UDI	Class II	Active
Advanced Research Medical Trident SI Screw System	03-40-6	FDA UDI	Class II	Active
Advanced Research Medical Trident SI Screw System	03-35-13	FDA UDI	Class II	Active
Advanced Research Medical Trident SI Screw System	03-45-13	FDA UDI	Class II	Active
Advanced Research Medical Trident SI Screw System	03-08	FDA UDI	Class II	Active
Lumbar Interbody Fusion System (OLLIF)	01-10	FDA UDI	Class II	Active
Advanced Research Medical Trident SI Screw System	03-35-6	FDA UDI	Class II	Active
Lumbar Interbody Fusion System (OLLIF)	01-07	FDA UDI	Class II	Active
Lumbar Interbody Fusion System (OLLIF)	01-3013	FDA UDI	Class II	Active
Lumbar Interbody Fusion System (OLLIF)	01-00-2	FDA UDI	Class II	Active
Lumbar Interbody Fusion System (OLLIF)	01-P2	FDA UDI	Class II	Active
Lumbar Interbody Fusion System (OLLIF)	01-3010	FDA UDI	Class II	Active
Lumbar Interbody Fusion System (OLLIF)	01-05	FDA UDI	Class II	Active
Lumbar Interbody Fusion System (OLLIF)	01-2709	FDA UDI	Class II	Active
Advanced Research Medical Trident SI Screw System	03-60-13	FDA UDI	Class II	Active
Lumbar Interbody Fusion System (OLLIF)	01-2712	FDA UDI	Class II	Active
Lumbar Interbody Fusion System (OLLIF)	01-9080-18U	FDA UDI	Class II	Active
Advanced Research Medical Trident SI Screw System	03-C1	FDA UDI	Class II	Active
Advanced Research Medical Trident SI Screw System	03-15	FDA UDI	Class II	Active
Advanced Research Medical Trident SI Screw System	03-55-13	FDA UDI	Class II	Active
Lumbar Interbody Fusion System (OLLIF)	01-09	FDA UDI	Class II	Active
Lumbar Interbody Fusion System (OLLIF)	01-C2	FDA UDI	Class II	Active
Lumbar Interbody Fusion System (OLLIF)	01-2001	FDA UDI	Class II	Active
Advanced Research Medical Trident SI Screw System	03-11-2	FDA UDI	Class II	Active
Lumbar Interbody Fusion System (OLLIF)	01-3008	FDA UDI	Class II	Active
Advanced Research Medical Trident SI Screw System	03-45-6	FDA UDI	Class II	Active
Advanced Research Medical Trident SI Screw System	03-55-6	FDA UDI	Class II	Active
Lumbar Interbody Fusion System (OLLIF)	01-04-3	FDA UDI	Class II	Active
Lumbar Interbody Fusion System (OLLIF)	01-C3	FDA UDI	Class II	Active
Lumbar Interbody Fusion System (OLLIF)	01-14-5	FDA UDI	Class II	Active
Advanced Research Medical Trident SI Screw System	03-11-1	FDA UDI	Class II	Active
Advanced Research Medical Trident SI Screw System	03-30-6	FDA UDI	Class II	Active
Advanced Research Medical Trident SI Screw System	03-P1	FDA UDI	Class I	Active
Lumbar Interbody Fusion System (OLLIF)	01-03	FDA UDI	Class II	Active
Lumbar Interbody Fusion System (OLLIF)	01-15	FDA UDI	Class II	Active
Lumbar Interbody Fusion System (OLLIF)	01-04-1	FDA UDI	Class II	Active
Lumbar Interbody Fusion System (OLLIF)	O-3000	FDA UDI	Class II	Active
Advanced Research Medical Trident SI Screw System	03-85-13	FDA UDI	Class II	Active
Lumbar Interbody Fusion System (OLLIF)	01-04-2	FDA UDI	Class II	Active
Lumbar Interbody Fusion System (OLLIF)	01-3314	FDA UDI	Class II	Active
Lumbar Interbody Fusion System (OLLIF)	01-3313	FDA UDI	Class II	Active

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