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Alamo C

FDA 510(k)

Class II (US FDA 510(k))

510(k) K112361

by Alliance Partners Llc

Identifiers

510(k) Number
K112361 FDA 510(k)
FDA Product Code
ODP FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3080 FDA 510(k)
Regulation Number
888.3080 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Alamo C is an interbody fusion device indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level from C2-T1. It is designed to provide structural support and promote fusion between adjacent vertebrae following discectomy.

The device is supplied by Alliance Partners, LLC and is regulated under FDA Class II (moderate risk) with product code ODP. It is intended for single use in a surgical setting and must be implanted by a qualified surgeon. Storage conditions and specific handling instructions are not detailed in the available data.

Frequently asked questions

What is the Alamo C used for?

The Alamo C is an interbody fusion device used in anterior cervical interbody fusion procedures. It is indicated for skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level from C2-T1, providing structural support to promote fusion between adjacent vertebrae following discectomy.

Is the Alamo C supplied sterile?

The available device data does not specify whether the Alamo C is supplied sterile. Clinicians should consult the manufacturer's labeling or contact Alliance Partners, LLC directly to confirm sterility status and any required aseptic handling prior to implantation.

Can the Alamo C be reused after implantation?

No, the Alamo C is intended for single use only. It must be implanted by a qualified surgeon in a surgical setting and should not be reprocessed or reused under any circumstances.

What are the storage requirements for the Alamo C?

The available device data does not include specific storage conditions or handling instructions for the Alamo C. Users should refer to the manufacturer's product labeling or contact Alliance Partners, LLC for detailed storage and handling guidelines.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ALAMO C by ALLIANCE PARTNERS, LLC | FDA 510 (k) Summary, Alamo C Interbody Fusion Device — FDA Class II Medical Device ..., ALLIANCE PARTNERS LLC 0107-1705 Alamo C - RevMed, PDF Alliance Partners, LLC - Food and Drug Administration, Alamo C Interbody Fusion Device — FDA Class II Medical Device ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Alliance Partners Llc
FDA Applicant
Alliance Partners, LLC

Sources (1)

  • FDA 510(k) K112361 24 fields · synced Sep 23, 2026