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	6118-4044S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6134-3550S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6131-3560	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6113-3514S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6125-41535S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6117-3528	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6111-4016	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	1025-7050S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6111-3550	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	1025-7055S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6142-1069S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6105-0000	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6601-3513S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6114-4014	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6124-3504S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6115-3522	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6601-3514	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6117-3550	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6111-3512	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6126-61525S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6113-3538	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6142-3240	FDA UDI	Class II	Active
Elatus Lumbar Plate System	7302-5525S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6601-3511S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6602-3520S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	CS02-0709	FDA UDI	Class I	Active
Elatus Lumbar Plate System	5426-2438S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6712-1749S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6105-0000S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6139-3550S	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	SI01-0113	FDA UDI	Class I	Active
Paeon Posterior Cervical Fixation System	6115-3536S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6131-3550S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6116-4020	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6116-3528S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6125-51540	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6121-3511	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6602-4021S	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	SI01-0203	FDA UDI	Class I	Active
ZESPIN SI Joint Fusion System	1024-2070	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6145-0018S	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	1024-2045S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6202-5030S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6607-3522S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6124-3515	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6116-4020S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6145-0010S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6135-3550	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6201-5530S	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	SI01-0111	FDA UDI	Class I	Active

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