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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 10 of 43

Device	Model / Reference	Registries	Class	Status
Paeon Posterior Cervical Fixation System	6123-3505S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6113-3526	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6116-3546S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6113-4036S	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	SI01-0414	FDA UDI	Class I	Active
Paeon Posterior Cervical Fixation System	6111-3532	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6112-4010S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6714-1785	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6114-4024	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6608-3512S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6202-4550S	FDA UDI	Class II	Active
Elatus Lumbar Plate System	5015-1426S	FDA UDI	Class II	Active
ABTross ALIF Expandable Cage System	2432-2506S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6608-4021S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6601-4010S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6713-1757S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6111-3542	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6123-3512S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6133-3550S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6203-5030	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6141-3001S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6602-4015S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6114-3532S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6119-4026S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6117-3518S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6115-4042S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6201-5520	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6126-51530S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6116-3522S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6117-4038S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6601-3514S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	CP02-0010	FDA UDI	Class I	Active
Paeon Posterior Cervical Fixation System	6121-3515	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6117-4036	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6608-4018	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6123-3503	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6116-3512S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6118-4046S	FDA UDI	Class II	Active
Elatus Lumbar Plate System	7101-5525S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6601-3516	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6125-42015	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6203-5045S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6111-3542S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6122-3507	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6116-3536	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	1025-7035S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6135-3535S	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	1025-8040S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	CS02-0204	FDA UDI	Class I	Active
Paeon Posterior Cervical Fixation System	6142-3149	FDA UDI	Class II	Active

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