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	6131-3570S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6126-52010	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6138-3535	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6118-4024S	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	1022-2070S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6113-4040	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6118-4020S	FDA UDI	Class II	Active
Elatus Lumbar Plate System	7301-5525S	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	1022-2065S	FDA UDI	Class II	Active
Elatus Lumbar Plate System	5015-1527	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6112-4034	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	SI01-0404	FDA UDI	Class I	Active
Paeon Posterior Cervical Fixation System	6125-52010	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6131-3540S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6119-3524S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6607-4012S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6123-3502S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6113-4026S	FDA UDI	Class II	Active
ABTross ALIF Expandable Cage System	2938-3012S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6111-3530S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6142-1068S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6112-4038	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6145-0020	FDA UDI	Class II	Active
Elatus Lumbar Plate System	7102-5530S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6601-3520S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6142-2139	FDA UDI	Class II	Active
ABTross ALIF Expandable Cage System	2938-2509S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6111-4038S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6112-3516	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6123-3507S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6111-3544	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6142-3249S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6125-41525S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6134-3535	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6121-3516	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6125-42010S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6125-61520	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6119-4048	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6134-3580	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6116-4018	FDA UDI	Class II	Active
Elatus Lumbar Plate System	7301-6025S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6202-4540S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6121-3517S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6118-3548	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6714-1777	FDA UDI	Class II	Active
Elatus Lumbar Plate System	7102-6055S	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	1023-6070S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6117-3536S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6121-3502S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6117-3518	FDA UDI	Class II	Active

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