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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 3 of 43

Device	Model / Reference	Registries	Class	Status
Paeon Anterior Cervical Plate System	6711-1727S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6115-3540	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6607-4012	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6203-5050S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6112-3546	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6121-3517	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6115-3550S	FDA UDI	Class II	Active
ABTross ALIF Expandable Cage System	2938-0812S	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	SI01-0201	FDA UDI	Class I	Active
ZESPIN SI Joint Fusion System	1025-7070	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	CP02-0602-AU	FDA UDI	Class I	Active
Paeon Posterior Cervical Fixation System	6125-51525S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6602-4014S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6112-3544S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6126-51020S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6114-3526S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6134-3545	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6608-4022	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6123-3516S	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	1022-2040S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6602-3514	FDA UDI	Class II	Active
Elatus Lumbar Plate System	7301-5535S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6122-3512S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6118-4020	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6119-4050S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6125-61025	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6114-4024S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6111-4030S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6113-4050S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6112-4048	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6124-3508S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6142-2238	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6608-4011S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6112-3528S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6114-4044	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6142-2250	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	CP02-0009	FDA UDI	Class I	Active
Paeon Anterior Cervical Plate System	6601-4017S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6112-3538S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	CP02-CM05	FDA UDI	Class I	Active
Paeon Posterior Cervical Fixation System	6114-4046	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6113-4022	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6111-3522S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6602-3521S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6113-3530S	FDA UDI	Class II	Active
Elatus Lumbar Plate System	LP01-1703	FDA UDI	Class I	Active
Paeon Posterior Cervical Fixation System	6112-3548	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6112-4042S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6118-3518	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6111-3532S	FDA UDI	Class II	Active

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