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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 38 of 43

Device	Model / Reference	Registries	Class	Status
Paeon Posterior Cervical Fixation System	6114-4050	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6113-4028	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6126-61025	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6118-3546	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	CS02-0103	FDA UDI	Class I	Active
Paeon Posterior Cervical Fixation System	6126-41540S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6119-3530	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6117-3544	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6118-3536	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	1024-2035	FDA UDI	Class II	Active
ABTross ALIF Expandable Cage System	2432-3006S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6601-4014S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6111-4018S	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	1025-7030	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6602-3516S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6116-4038	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6115-4028	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6114-4026S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6119-3528	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	1023-6035S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6111-4024	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6113-4044	FDA UDI	Class II	Active
Elatus Lumbar Plate System	5326-4054S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6142-3230S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6115-4018	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6114-3550	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6126-41530S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6126-61030	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6115-3550	FDA UDI	Class II	Active
ABTross ALIF Expandable Cage System	2938-1509S	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	1022-2030S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6145-0019S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6136-3580	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6123-3517	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	1023-8060S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6118-4042S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6126-41020	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6117-4038	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	CS02-0402	FDA UDI	Class I	Active
Paeon Posterior Cervical Fixation System	6119-3542	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6134-3580S	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	1022-2055	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6201-5040S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6142-3269S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6111-3518	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6142-1038	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6713-1766S	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	1203-0006	FDA UDI	Class II	Active
ABTross ALIF Expandable Cage System	2432-2509S	FDA UDI	Class II	Active
ABTross ALIF Expandable Cage System	2432-3015S	FDA UDI	Class II	Active

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