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
Elatus Lumbar Plate System	2426-3852S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6116-4050	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6119-4018S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6116-4044S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6202-4525S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6142-3138	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	1022-1045	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6111-3544S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6116-4040	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6118-3530S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6713-1763S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6116-3540S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6115-3526S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6111-4032	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6115-4010	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6114-3542	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6133-3560S	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	SI01-0501	FDA UDI	Class I	Active
Paeon Posterior Cervical Fixation System	6142-3230	FDA UDI	Class II	Active
Paeon Cervical Plate System	6602-3513S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6118-3534	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6114-3542S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6117-4024	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6116-3514	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	SI01-0202	FDA UDI	Class I	Active
Paeon Anterior Cervical Plate System	6602-4021	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	1025-8060S	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	1023-6050S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6203-5020S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6111-3510	FDA UDI	Class II	Active
Elatus Lumbar Plate System	5015-2234S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6142-2230	FDA UDI	Class II	Active
ABTross ALIF Expandable Cage System	2432-1506S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6601-3515S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6203-5525S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6712-1741	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6713-1742S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6141-1001	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6711-1725	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6121-3504S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6602-4020	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6126-61520	FDA UDI	Class II	Active
ABTross ALIF Expandable Cage System	2938-2012S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6112-3524S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6142-3158	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6607-3514S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	CP02-0011	FDA UDI	Class I	Active
Elatus Lumbar Plate System	5015-3042S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	CP02-0705	FDA UDI	Class I	Active
ABTross ALIF Expandable Cage System	2938-1512S	FDA UDI	Class II	Active

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