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 Anterior Cervical Plate System	6607-4022	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6202-5525S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6201-5050	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6117-3534	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6117-3542S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6132-3560S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6116-3540	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6131-3535S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6116-3530	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6122-3504	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6122-3513S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6115-3512	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	1023-7040S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6712-1733S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6607-3519	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6143-3560S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6201-5525	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6116-4012S	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	1023-7060S	FDA UDI	Class II	Active
Elatus Lumbar Plate System	5426-2034S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6202-4540	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6123-3524	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6113-4032S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6113-3548	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	1022-1050S	FDA UDI	Class II	Active
Elatus Lumbar Plate System	5326-1832S	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	1025-7055	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6602-3514S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6114-3538S	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	1022-1045S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6142-3130	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6602-3510S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6711-1731S	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	1022-2045	FDA UDI	Class II	Active
ABTross ALIF Expandable Cage System	2938-2506S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6608-3521	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6116-4048	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6123-3510	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6119-4038S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6113-3512S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6608-3518S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6714-1789S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6117-4046	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6114-4022S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6125-62015S	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	SI01-0312	FDA UDI	Class I	Active
Paeon Posterior Cervical Fixation System	6112-4016	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	1022-2035S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6111-3548	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6607-4013S	FDA UDI	Class II	Active

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