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
Elatus Lumbar Plate System	2426-1832S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6121-3509	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6112-4014	FDA UDI	Class II	Active
Elatus Lumbar Plate System	7301-5550S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6114-4014S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6113-3538S	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	1023-7070	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6201-5535	FDA UDI	Class II	Active
Elatus Lumbar Plate System	5326-2438S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6126-41030S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6602-4016S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6122-3507S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6118-3544	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6118-3532	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6203-5530	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6124-3511	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6119-4030S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6136-3545S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6114-3520	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6119-3522S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6116-4014S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6142-1040S	FDA UDI	Class II	Active
Elatus Lumbar Plate System	7301-5545S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6711-1723S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6112-3546S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6142-3159S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6126-41520S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6123-3513S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6112-4012	FDA UDI	Class II	Active
ABTross ALIF Expandable Cage System	2938-2006S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	CP02-0601	FDA UDI	Class I	Active
Paeon Posterior Cervical Fixation System	6116-4046S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6142-1058S	FDA UDI	Class II	Active
ABTross ALIF Expandable Cage System	2938-2512S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	CS02-0401	FDA UDI	Class I	Active
Paeon Posterior Cervical Fixation System	6113-3510	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	SI01-0502	FDA UDI	Class I	Active
Paeon Posterior Cervical Fixation System	6114-4034	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6142-3148	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6608-3522	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	1024-2030S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6113-4028S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6111-3550S	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	1203-0007	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6112-3534	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6601-4019	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6602-4010S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6712-1745	FDA UDI	Class II	Active
Elatus Lumbar Plate System	5426-4054S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6111-3516	FDA UDI	Class II	Active

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