Question 1

What types of medical devices does Aegis Spine, Inc. manufacture?

Accepted Answer

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.

Question 2

Where is Aegis Spine, Inc. based?

Accepted Answer

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.

Question 3

Which regulatory registries or databases list Aegis Spine, Inc.’s devices?

Accepted Answer

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.

Question 4

How are Aegis Spine, Inc.’s devices classified under FDA regulations?

Accepted Answer

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.

Question 5

What are some examples of devices produced by Aegis Spine, Inc.?

Accepted Answer

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.

Device	Model / Reference	Registries	Class	Status
Paeon Posterior Cervical Fixation System	6126-51035S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6202-5045S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6125-51535S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6203-4535S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6112-4028S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6201-5025	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6138-3580	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6121-3509S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6117-3532	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6203-5550	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6143-3545S	FDA UDI	Class II	Active
Elatus Lumbar Plate System	LP01-0203	FDA UDI	Class I	Active
Paeon Posterior Cervical Fixation System	6115-3538	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6119-3528S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6601-3510	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	CP02-0314	FDA UDI	Class I	Active
Elatus Lumbar Plate System	7101-5545S	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	SI01-0102	FDA UDI	Class I	Active
Paeon Posterior Cervical Fixation System	6145-0017	FDA UDI	Class II	Active
Elatus Lumbar Plate System	5215-2638S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6113-4042S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6112-4032S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6111-3538	FDA UDI	Class II	Active
Elatus Lumbar Plate System	5426-3044S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6112-3548S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6123-3505	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	CP02-0201	FDA UDI	Class I	Active
Paeon Anterior Cervical Plate System	6713-1760S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6202-4530	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	1023-6060S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6608-4016	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	CS02-0404	FDA UDI	Class I	Active
Paeon Posterior Cervical Fixation System	6121-3518	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6141-2001	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	1025-7065S	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	1022-2055S	FDA UDI	Class II	Active
Elatus Lumbar Plate System	7301-6035S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6202-5520S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6142-2160S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6116-3534S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6114-3514S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6118-4050	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6116-3550	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6136-3560	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6126-51020	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6711-1721S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6137-3545	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6118-4018	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6131-3550	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6119-3518	FDA UDI	Class II	Active

Aegis Spine, Inc.

What Aegis Spine, Inc. makes

Frequently asked questions

Information

Catalogue (2134)

Related Companies

Authorised Representatives

Importers

Notified Bodies

Authorities