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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: —
Website: —
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EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 017993061

Catalogue (2134)

Page 40 of 43

Device	Model / Reference	Registries	Class	Status
Paeon Posterior Cervical Fixation System	6113-3542	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6112-3532	FDA UDI	Class II	Active
Elatus Lumbar Plate System	5015-3446S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6112-4032	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6113-4010S	FDA UDI	Class II	Active
Elatus Lumbar Plate System	2426-2438S	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	1022-2065	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6203-4530	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6116-3548S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	CS02-0703	FDA UDI	Class I	Active
Paeon Posterior Cervical Fixation System	6123-3510S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6118-3534S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6116-4038S	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	SI01-0214	FDA UDI	Class I	Active
Paeon Posterior Cervical Fixation System	CS02-0705	FDA UDI	Class I	Active
Paeon Posterior Cervical Fixation System	6202-5045	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6712-1737	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6201-5535S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6137-3535	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6125-41025S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6602-3521	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6125-61525S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6125-41535	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6112-4024S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6608-3515S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6202-5020S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6126-61540	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	1023-8065S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6601-3517S	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	SI01-0413	FDA UDI	Class I	Active
Paeon Posterior Cervical Fixation System	CS02-0707	FDA UDI	Class I	Active
Paeon Posterior Cervical Fixation System	6202-5540S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6126-51030S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6203-5035S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6145-0014S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6201-5045	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6115-4030S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6114-4020S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6119-3538S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6121-3518S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6125-51530	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6113-4010	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6111-4036S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6142-2268S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6124-3502	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6126-52010S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6602-4018S	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	1022-1065	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6201-5040	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6123-3515S	FDA UDI	Class II	Active

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