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 9 of 43

Device	Model / Reference	Registries	Class	Status
ZESPIN SI Joint Fusion System	1025-7035	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6145-0017S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6138-3565S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6113-3514	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6119-3532	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6121-3511S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6116-4018S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6102-6036S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6126-61530S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6115-4050S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6118-3530	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6142-3140	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6115-3548S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6142-3168	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6608-3520	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6142-1048S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6142-2148	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6132-3560	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6124-3512	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6118-4032	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	SI01-0215	FDA UDI	Class I	Active
Paeon Posterior Cervical Fixation System	6111-4046	FDA UDI	Class II	Active
Elatus Lumbar Plate System	7302-6045S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6126-51040S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6115-4032S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6116-4016	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6713-1757	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6125-41540S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6134-3565	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6123-3504	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6601-4017	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	1023-8070	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6112-4014S	FDA UDI	Class II	Active
Elatus Lumbar Plate System	7302-6025S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6138-3565	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6117-4024S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6125-51040	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6141-1003S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6203-5040	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6142-2168	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6607-4017	FDA UDI	Class II	Active
Elatus Lumbar Plate System	7102-5540S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6202-5550	FDA UDI	Class II	Active
Elatus Lumbar Plate System	2426-2034S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6201-5035S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6115-3532	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6111-4048S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6116-3516S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6122-3509	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6118-3524S	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.