Question 1

What types of medical devices does Aegis Spine, Inc. manufacture?

Accepted Answer

Aegis Spine, Inc. specializes in spinal fixation hardware, including bone-screw systems (both sterile and non-sterile), non-bioabsorbable spinal plates and screws, metallic spinal interbody fusion cages, and sacroiliac joint fixation implants (uncoated and non-sterile). Their product line also covers reusable surgical drill guides, designed to support spinal stabilization procedures.

Question 2

Where is Aegis Spine, Inc. based?

Accepted Answer

Aegis Spine, Inc. is headquartered in the United States. The company’s location is relevant for regulatory compliance and device distribution, particularly for FDA-related processes.

Question 3

Which regulatory registries or databases list Aegis Spine, Inc.’s devices?

Accepted Answer

Aegis Spine, Inc.’s devices are listed in the FDA’s Unique Device Identification (UDI) database. This registry ensures traceability and transparency in the medical device supply chain, helping healthcare providers and regulators verify product details.

Question 4

How are Aegis Spine, Inc.’s devices classified under FDA regulations?

Accepted Answer

Aegis Spine, Inc.’s devices fall under FDA’s Class I and Class II classifications. Class I generally includes low-risk devices requiring general controls, while Class II involves additional performance standards or special controls due to moderate risk. Classification determines the regulatory pathway for authorization.

Question 5

What are some examples of devices produced by Aegis Spine, Inc.?

Accepted Answer

Among the devices produced by Aegis Spine, Inc. are the Paeon Posterior Cervical Fixation System (used for cervical spine stabilization) and the Elatus Lumbar Plate System (for lumbar spine fixation). These systems are designed to address specific spinal conditions requiring surgical intervention.

Device	Model / Reference	Registries	Class	Status
Paeon Posterior Cervical Fixation System	6131-3560S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6118-4036	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	SI01-0303	FDA UDI	Class I	Active
Paeon Posterior Cervical Fixation System	6111-4040S	FDA UDI	Class II	Active
ABTross ALIF Expandable Cage System	2432-2006S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6114-4022	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6111-3540S	FDA UDI	Class II	Active
Elatus Lumbar Plate System	5015-2638S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6601-3513	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6136-3535	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6607-4013	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6119-4038	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6201-5030S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6113-4048	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6114-3512S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6137-3535S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6125-61530S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6119-4034	FDA UDI	Class II	Active
Elatus Lumbar Plate System	5215-3244S	FDA UDI	Class II	Active
Elatus Lumbar Plate System	7301-5530S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6125-61020	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6142-3169S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6119-4018	FDA UDI	Class II	Active
Elatus Lumbar Plate System	LP01-0602	FDA UDI	Class I	Active
Paeon Posterior Cervical Fixation System	6123-3502	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6113-4026	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6601-4010	FDA UDI	Class II	Active
Elatus Lumbar Plate System	7302-5530S	FDA UDI	Class II	Active
Elatus Lumbar Plate System	7102-5535S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6119-3548	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6117-3532S	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	SI01-0316	FDA UDI	Class I	Active
Paeon Posterior Cervical Fixation System	6116-3546	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6712-1731S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6111-3534S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6117-3530S	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	SI01-0403	FDA UDI	Class I	Active
Paeon Anterior Cervical Plate System	6608-4020S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6601-4014	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6132-3540S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6126-52015	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6122-3511	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6201-4530S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6711-1725S	FDA UDI	Class II	Active
Elatus Lumbar Plate System	7301-5555S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6142-3258	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	CP02-CM08	FDA UDI	Class I	Active
Paeon Posterior Cervical Fixation System	6136-3550	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6135-3580S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6116-3518	FDA UDI	Class II	Active

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