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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 15 of 43

Device	Model / Reference	Registries	Class	Status
Paeon Posterior Cervical Fixation System	6121-3506	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6201-5540	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6142-2269	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6118-4034	FDA UDI	Class II	Active
Elatus Lumbar Plate System	5326-2640S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6112-3542S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6117-4036S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6122-3502S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6111-4022	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6713-1766	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	CP02-0003	FDA UDI	Class I	Active
Paeon Posterior Cervical Fixation System	6111-4034S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6118-3520	FDA UDI	Class II	Active
Elatus Lumbar Plate System	2426-3246S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6714-1765S	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	1023-6040	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6602-3522	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6142-1030	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6608-3511S	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	1203-0008S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6201-4545	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6126-61035S	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	SI01-0315	FDA UDI	Class I	Active
Paeon Posterior Cervical Fixation System	6122-3510	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6117-3534S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6116-4042	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6142-2169S	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	1023-7045S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6711-1719S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6125-61040S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	CS02-0704	FDA UDI	Class I	Active
Paeon Posterior Cervical Fixation System	6119-3550S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6112-3524	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6142-3150S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6125-41020	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6115-4030	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6139-3580S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6113-4012	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6125-62010	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6142-2240S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6118-4046	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6122-3512	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6113-3518	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6602-4019S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6118-3528S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6114-4036S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6608-3510	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6104-7037	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6602-3511	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6116-3512	FDA UDI	Class II	Active

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