Is this your brand? Sign in to claim ownership.

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: —
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 017993061

Catalogue (2134)

Page 29 of 43

Device	Model / Reference	Registries	Class	Status
Paeon Posterior Cervical Fixation System	6142-1050	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6713-1772	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6141-3003S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6201-5030	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6141-2003S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6117-3530	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6124-3514	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6137-3565S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6601-3519S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6111-4038	FDA UDI	Class II	Active
Elatus Lumbar Plate System	7302-5555S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6112-3540S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6117-3542	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6113-3548S	FDA UDI	Class II	Active
Elatus Lumbar Plate System	7102-6035S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6113-3530	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	1023-8045	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6202-5545	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6142-3268	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6601-4019S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6119-4024	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6119-3526	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6141-1002	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6121-3508	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6115-3544	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6103-7037S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6122-3515S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6126-51535	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6122-3502	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6713-1745S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6126-41030	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6111-3520	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6602-4020S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6601-4016	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	1022-1050	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6117-4028S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6203-5520S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6125-51530S	FDA UDI	Class II	Active
ABTross ALIF Expandable Cage System	2432-0809S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6139-3545S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6142-2238S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6118-4032S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6111-4010	FDA UDI	Class II	Active
ABTross ALIF Expandable Cage System	2938-1209S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6601-4021S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6142-2138S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6118-4038S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6125-41530	FDA UDI	Class II	Active
ABTross ALIF Expandable Cage System	2432-2009S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6607-4015	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.