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	6142-3240S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6121-3514	FDA UDI	Class II	Active
Elatus Lumbar Plate System	7302-6050S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6125-42010	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6122-3505	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6118-4050S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6116-3524	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6713-1751	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6111-4020	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6714-1785S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6714-1777S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6132-3535S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6116-4026S	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	1023-8045S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6113-3516S	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6601-3517	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6123-3509S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6118-3532S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6142-2148S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6114-3526	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6607-4010	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6601-4015	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6711-1735	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	1022-2070	FDA UDI	Class II	Active
Paeon Anterior Cervical Plate System	6607-3519S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6119-4020	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6115-4020S	FDA UDI	Class II	Active
Paeon Posterior Cervical Fixation System	6126-42015	FDA UDI	Class II	Active
ZESPIN SI Joint Fusion System	K223521	FDA 510(k)	Class II	Active
XYPAN Expandable Lumbar Cage System	K203531	FDA 510(k)	Class II	Active
ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, Spinema Lumbar Plate System	K221050	FDA 510(k)	Class II	Active
ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix Anterior Cervical Plate System, Spinema Lumbar Plate System	K210035	FDA 510(k)	Class II	Active
Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System	K223719	FDA 510(k)	Class II	Active
ABTross ALIF Expandable Cage System	K221719	FDA 510(k)FDA UDI	Class II	Active

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