Question 1

What types of medical devices does Addivation Medical, LLC primarily manufacture?

Accepted Answer

Addivation Medical, LLC specialises in spinal fusion spheres, specifically cervical interbody devices. These devices are designed for intervertebral disc replacement in the cervical spine, offering structural support and stability during spinal fusion procedures. The focus is on Class II devices tailored for spinal applications.

Question 2

Where is Addivation Medical, LLC based, and what does that imply about its regulatory oversight?

Accepted Answer

Addivation Medical, LLC is based in the United States, meaning its devices fall under FDA jurisdiction. Since the company’s products are Class II devices, they undergo FDA review through pathways like the 510(k) premarket notification process or Unique Device Identification (UDI) requirements, ensuring compliance with US medical device regulations.

Question 3

Which regulatory registries or databases list Addivation Medical, LLC’s devices?

Accepted Answer

Addivation Medical, LLC’s devices are listed in the FDA’s 510(k) premarket notification database and the FDA’s Unique Device Identifier (UDI) system. These registries track authorised Class II devices, confirming their compliance with US regulatory requirements before market introduction.

Question 4

How are Addivation Medical, LLC’s devices classified under FDA regulations?

Accepted Answer

Addivation Medical, LLC’s devices are classified as Class II under FDA regulations. This classification applies to moderate-risk medical devices that require special controls beyond general controls to ensure safety and effectiveness, such as cervical interbody fusion devices, which necessitate rigorous validation for structural integrity and clinical performance.

Device	Model / Reference	Registries	Class	Status
Addivation Medical Cervical Interbody Device	AOCS6148	FDA UDI	Class II	Active
Addivation Medical Cervical Interbody Device	AOCS6149	FDA UDI	Class II	Active
Addivation Medical Cervical Interbody Device	AOCS6121	FDA UDI	Class II	Active
Addivation Medical Cervical Interbody Device	AOCS6120	FDA UDI	Class II	Active
Addivation Medical Cervical Interbody Device	AOCS6140	FDA UDI	Class II	Active
Addivation Medical Cervical Interbody Device	AOCS6122	FDA UDI	Class II	Active
Addivation Medical Cervical Interbody Device	AOCS6127	FDA UDI	Class II	Active
Addivation Medical Cervical Interbody Device	AOCS6129	FDA UDI	Class II	Active
Addivation Medical Cervical Interbody Device	AOCS6141	FDA UDI	Class II	Active
Addivation Medical Cervical Interbody Device	AOCS6146	FDA UDI	Class II	Active
Addivation Medical Cervical Interbody Device	AOCS6125	FDA UDI	Class II	Active
Addivation Medical Cervical Interbody Device	AOCS6147	FDA UDI	Class II	Active
Addivation Medical Cervical Interbody Device	AOCS6145	FDA UDI	Class II	Active
Addivation Medical Cervical Interbody Device	AOCS6142	FDA UDI	Class II	Active
Addivation Medical Cervical Interbody Device	AOCS6126	FDA UDI	Class II	Active
Addivation Medical Cervical Interbody Device	AOCS6128	FDA UDI	Class II	Active
Addivation Medical Cervical Interbody System	K190291	FDA 510(k)	Class II	Active

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