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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 35 of 43

Device	Model / Reference	Registries	Class	Status
Paeon Posterior Cervical Fixation System	6126-51525S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6116-3514S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	CS02-0104	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6117-3546	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6131-3535	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6124-3503	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6119-3522	FDA UDI	Class II	Active
Elatus Lumbar Plate System	7101-5535S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6118-3550	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	SI01-0115	FDA UDI	Class I	Active
Paeon Posterior Cervical Fixation System	6134-3545S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6125-41030S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6124-3509	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6115-4016	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6117-3522S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6119-3538	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6126-51540S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6123-3513	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6111-4028	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6607-3516S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6111-4022S	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	1025-7040S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6112-4048S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6112-4022	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6116-4028S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6125-61035S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6114-3524S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6113-4024	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6123-3514S	FDA UDI	Class II	Active
ABTross ALIF Expandable Cage System	2432-1212S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6607-4011S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6112-4046	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6122-3513	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6114-4046S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6608-3515	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6601-4020S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6121-3513S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6126-42010	FDA UDI	Class II	Active
Elatus Lumbar Plate System	7101-6035S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6201-4540	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6142-2158	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	1023-6070	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	1023-6065S	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	1023-8065	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6203-4540S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6113-4024S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6714-1773S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6101-6036S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6608-3518	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6114-4048S	FDA UDI	Class II	Active

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