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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 11 of 43

Device	Model / Reference	Registries	Class	Status
Paeon Posterior Cervical Fixation System	6115-4046	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6608-4010	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	1023-8050	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6116-4012	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6115-3542S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6111-4048	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6126-61530	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6201-5520S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6145-0011S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6114-4030	FDA UDI	Class II	Active
Elatus Lumbar Plate System	5326-3246S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6114-3528S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6113-3516	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6118-3544S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6602-4013S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6117-4044S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6114-3536S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6608-3516	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6121-3524	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6112-4050	FDA UDI	Class II	Active
Elatus Lumbar Plate System	LP01-0704	FDA UDI	Class I	Active
Paeon Posterior Cervical Fixation System	6122-3511S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6142-3269	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6712-1743	FDA UDI	Class II	Active
Elatus Lumbar Plate System	2426-3650S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6142-3239	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6126-61525	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6114-3534	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6117-4042	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6116-3542S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6202-5050	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6711-1721	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6143-3535	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6115-3548	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6117-3540	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6116-3524S	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	1025-8035S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	CS02-0203	FDA UDI	Class I	Active
Paeon Posterior Cervical Fixation System	6112-3522S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6115-4048	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6142-2150	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6126-61020	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6714-1789	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6608-4013	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	CP02-0701	FDA UDI	Class I	Active
Paeon Posterior Cervical Fixation System	6113-3528S	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	1023-6065	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6123-3503S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6118-3520S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6138-3535S	FDA UDI	Class II	Active

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