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Aegis Spine, Inc.

Last updated May 23, 2026

What Aegis Spine, Inc. makes

Aegis Spine, Inc. manufactures spinal fixation hardware, including bone-screw systems (both sterile and non-sterile), non-bioabsorbable spinal plates and screws, metallic interbody fusion cages, and sacroiliac joint fixation implants (uncoated and non-sterile). Their portfolio also includes reusable surgical drill guides. The Paeon Posterior Cervical Fixation System and Elatus Lumbar Plate System are among the devices they produce for spinal stabilization procedures.

The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identification (UDI) database. The manufacturer is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

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

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.

Where is Aegis Spine, Inc. based?

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.

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

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.

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

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.

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

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.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: US
Address: —
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EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 017993061

Catalogue (2134)

Page 8 of 43

Device	Model / Reference	Registries	Class	Status
ZESPIN SI Joint Fusion System	1025-8060	FDA UDI	Class II	Active
ABTross ALIF Expandable Cage System	2938-3009S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6113-3522	FDA UDI	Class II	Active
Elatus Lumbar Plate System	7302-5520S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6602-4011S	FDA UDI	Class II	Active
Elatus Lumbar Plate System	5426-2236S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6125-62010S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6121-3515S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6712-1743S	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	SI01-0106	FDA UDI	Class I	Active
Paeon Posterior Cervical Fixation System	6119-4028S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6115-4044S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6111-4014	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	CS02-0706	FDA UDI	Class I	Active
Paeon Posterior Cervical Fixation System	6113-4050	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6126-61540S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6118-4034S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6203-5545	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6119-4022	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6126-41040	FDA UDI	Class II	Active
Elatus Lumbar Plate System	7302-6055S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6713-1745	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6118-4042	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6114-3522	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6607-3521	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6201-4525S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6142-3168S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6119-4042S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6115-4032	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6142-3238	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6121-3507S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6115-3516	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6713-1754S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6115-4040	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6201-5025S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6121-3505	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6124-3503S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6124-3506	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6602-3520	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6142-3239S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6125-51535	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6607-3518	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6118-4030S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6116-4048S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6114-4040	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6125-61020S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6117-3538	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6119-4028	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6113-4042	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	CP02-0801	FDA UDI	Class I	Active

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