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	6114-3546S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6112-3542	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	SI01-0107	FDA UDI	Class I	Active
ZESPIN SI Joint Fusion System	1025-8065S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6121-3513	FDA UDI	Class II	Active
Elatus Lumbar Plate System	7102-6045S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6114-4042S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6116-3520S	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	1023-7055	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6713-1748S	FDA UDI	Class II	Active
ABTross ALIF Expandable Cage System	2938-2015S	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	1203-0008	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6201-5045S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6142-3260S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6123-3520S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6113-3524S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6714-1797	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6126-61535	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6142-2169	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	1022-2050	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	CP02-0004	FDA UDI	Class I	Active
Elatus Lumbar Plate System	2426-2842S	FDA UDI	Class II	Active
ABTross ALIF Expandable Cage System	2432-0815S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6137-3560	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6139-3565S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6139-3545	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6141-1003	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6126-61020S	FDA UDI	Class II	Active
Elatus Lumbar Plate System	7301-5540S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6607-3518S	FDA UDI	Class II	Active
ABTross ALIF Expandable Cage System	2938-1212S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6123-3507	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6202-5525	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	CS02-0202	FDA UDI	Class I	Active
Paeon Posterior Cervical Fixation System	6115-3512S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6202-5020	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6114-4010S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6601-3519	FDA UDI	Class II	Active
Elatus Lumbar Plate System	2426-2236S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6116-4034S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6115-4034S	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	SI01-0114	FDA UDI	Class I	Active
Paeon Posterior Cervical Fixation System	6122-3514S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6114-3514	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6602-3512	FDA UDI	Class II	Active
Elatus Lumbar Plate System	5215-3042S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6113-3546	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6202-4535	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6132-3540	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6114-4018	FDA UDI	Class II	Active

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