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	6602-4022	FDA UDI	Class II	Active
Elatus Lumbar Plate System	7101-5520S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6201-5545	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6142-1039	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6201-5035	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6118-4022	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6116-3522	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6203-5040S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6121-3510S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6117-4026S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6145-0020S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6203-4530S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6115-3528	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6143-3555S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6111-3516S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6123-3518S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6113-4032	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6608-3516S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6203-4520S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6132-3550	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6119-3546S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6601-4015S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6712-1741S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6118-4018S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6116-3518S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6118-3526	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6202-4545S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6125-61535	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6145-0013	FDA UDI	Class II	Active
Elatus Lumbar Plate System	5015-3648S	FDA UDI	Class II	Active
Elatus Lumbar Plate System	7302-5545S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6119-4048S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6113-3522S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6101-6036	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	1023-6030	FDA UDI	Class II	Active
ABTross ALIF Expandable Cage System	2938-0815S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6124-3510S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6115-3534	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6111-3518S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6112-3520	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6125-52010S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6118-3548S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6111-3546S	FDA UDI	Class II	Active
Elatus Lumbar Plate System	5015-3244S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6608-3514S	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	1203-0007S	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	1025-7060S	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	1022-2050S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6114-3522S	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	K223521	FDA UDI	Class II	Active

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