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
ZESPIN SI Joint Fusion System	1024-2035S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6145-0014	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6111-4010S	FDA UDI	Class II	Active
Elatus Lumbar Plate System	7302-6040S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6607-3510S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6142-2130S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6712-1733	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6113-4016	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6116-3510S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	CS02-0101	FDA UDI	Class I	Active
Paeon Anterior Cervical Plate System	6602-3518	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	1023-8035	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6111-4026S	FDA UDI	Class II	Active
Elatus Lumbar Plate System	5426-3448S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6142-3159	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6125-41040S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6142-3148S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6116-4030	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6123-3508S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6608-4014	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6601-4012	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6111-3536S	FDA UDI	Class II	Active
Elatus Lumbar Plate System	7101-5555S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6141-3001	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6119-3540S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6607-4011	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6114-3528	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6116-4014	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6125-61520S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6117-3540S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6115-4014S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6113-4038S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6111-3534	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6203-4535	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6711-1733S	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	1024-2065S	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	1023-7065S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6113-3536	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	1023-8055S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6711-1723	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6116-4026	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	SI01-0112A	FDA UDI	Class I	Active
ZESPIN SI Joint Fusion System	1023-7030S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6202-5040S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6711-1731	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6123-3520	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	CS02-0303	FDA UDI	Class I	Active
Paeon Posterior Cervical Fixation System	6203-5035	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6124-3505	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6202-5540	FDA UDI	Class II	Active

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