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	6145-0011	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	1022-1055	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	CP02-0001	FDA UDI	Class I	Active
Paeon Posterior Cervical Fixation System	6122-3508S	FDA UDI	Class II	Active
ABTross ALIF Expandable Cage System	2938-1506S	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	1023-6050	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6714-1793	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6202-4530S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6126-61025S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6126-42015S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6121-3503S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6115-4028S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6607-3513	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6114-4032S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6607-3521S	FDA UDI	Class II	Active
ABTross ALIF Expandable Cage System	2938-1515S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6601-3511	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6607-4018	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	CP02-0102	FDA UDI	Class I	Active
Paeon Posterior Cervical Fixation System	6113-4020S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6112-3526	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6117-4046S	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	1025-7065	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6124-3512S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6115-4022S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6118-4048	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	1024-2055S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6145-0018	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	1023-6030S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6112-3530S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6608-4015	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6142-3250	FDA UDI	Class II	Active
Elatus Lumbar Plate System	7102-5525S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6145-0015	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6142-1068	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6142-2160	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6145-0019	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	1022-1035	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6601-3516S	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	1023-7050	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6112-3510	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6116-3510	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6113-4034S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6115-3516S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6126-51535S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6139-3535S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6142-3139	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6125-52015S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6121-3504	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6136-3580S	FDA UDI	Class II	Active

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