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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 5 of 43

Device	Model / Reference	Registries	Class	Status
Paeon Posterior Cervical Fixation System	6115-3522S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6712-1735S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6142-1048	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6142-2240	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6203-5025S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6113-3526S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6712-1737S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6117-4018	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6135-3565	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6113-4022S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6607-4021	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6601-3510S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6131-3540	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6113-4036	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6104-7037S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6124-3502S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6117-4018S	FDA UDI	Class II	Active
Elatus Lumbar Plate System	7301-6045S	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	1025-8030S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6119-4032S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6119-3540	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6116-4032	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	1023-8055	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6115-3528S	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	1022-1060	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6607-4016	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6608-4019S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6608-3513	FDA UDI	Class II	Active
ABTross ALIF Expandable Cage System	2938-0809S	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	1024-2055	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6601-4013S	FDA UDI	Class II	Active
ABTross ALIF Expandable Cage System	2432-2515S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	CP02-0002	FDA UDI	Class I	Active
Paeon Posterior Cervical Fixation System	6201-4535	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6113-4018S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6143-3555	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6142-3160S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6116-4046	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6116-4036	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6117-3528S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6142-2149	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6119-3520	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6116-3538S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6115-3510S	FDA UDI	Class II	Active
Elatus Lumbar Plate System	7301-6040S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6126-41540	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6114-3544	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6112-3536S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6142-3248	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6137-3580	FDA UDI	Class II	Active

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