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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 14 of 43

Device	Model / Reference	Registries	Class	Status
Paeon Posterior Cervical Fixation System	6126-51530	FDA UDI	Class II	Active
Elatus Lumbar Plate System	5015-1527S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6142-1049	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6114-4012	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6203-5550S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6114-4032	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6139-3550	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6126-52015S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6126-41530	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6137-3550	FDA UDI	Class II	Active
Elatus Lumbar Plate System	LP01-0706	FDA UDI	Class I	Active
Paeon Posterior Cervical Fixation System	6117-3524	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6117-3536	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6119-3526S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6122-3506	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6116-3534	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6202-4520	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6118-4028S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6602-4014	FDA UDI	Class II	Active
Elatus Lumbar Plate System	7302-5550S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6113-3534S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6118-3526S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6112-3522	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6602-3522S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6142-2249S	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	SI01-0314	FDA UDI	Class I	Active
Paeon Posterior Cervical Fixation System	6118-4044	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6114-3524	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6607-3522	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6608-4020	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6113-3524	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6601-3522	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6135-3565S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6125-41520S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6119-4036S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	CS02-0708	FDA UDI	Class I	Active
Paeon Posterior Cervical Fixation System	6203-4545	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6142-2259S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6132-3570S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6141-2001S	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	1025-8040	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	CP02-0703	FDA UDI	Class I	Active
Paeon Posterior Cervical Fixation System	6111-3520S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6126-51025S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6121-3510	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6125-41525	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6203-4550S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6115-4034	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6113-3518S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6119-4044S	FDA UDI	Class II	Active

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