Identifiers
- 510(k) Number
- K133321 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 Anterior Cervical Interbody Fusion Device (Product Code: ODP), designed for spinal fusion procedures in the cervical spine. It is intended to stabilize and support the cervical vertebrae, facilitating bone growth across the intervertebral space to treat degenerative disc disease with associated radicular symptoms at one level from C2 to T1.
This device is supplied as a reusable orthopedic implant and is classified as a Class II Moderate Risk medical device under FDA regulations. It is manufactured by Alliance Partners, LLC, and requires sterile packaging for surgical use. The device is regulated under FDA 510(k) clearance (K173128) and is intended for use in orthopedic procedures within a hospital or surgical center setting.
Frequently asked questions
What types of cervical spine conditions is the Alamo C designed to address in surgical settings?
The Alamo C is specifically designed for spinal fusion procedures in the cervical spine to treat degenerative disc disease with associated radicular symptoms at a single level, ranging from C2 to T1. It is intended to stabilize and support the cervical vertebrae while facilitating bone growth across the intervertebral space.
Is the Alamo C intended for single-use or reusable applications in surgery?
The Alamo C is supplied as a reusable orthopedic implant, meaning it is intended to be used multiple times in surgical procedures after proper cleaning and sterilization. This classification aligns with its design for long-term spinal stabilization.
How is the Alamo C packaged for surgical use, and what does this imply about its handling?
The Alamo C is provided in sterile packaging to ensure it meets surgical standards for cleanliness and safety. This packaging is critical for maintaining sterility before use in orthopedic procedures, as it must remain uncontaminated until the time of implantation.
What regulatory pathway does the Alamo C follow, and what does this mean for its use in hospitals?
The Alamo C follows the FDA 510(k) clearance pathway, specifically with clearance number K173128 (though the provided data references K133321, the current regulatory status is tied to 510K). This means it has been deemed substantially equivalent to a legally marketed device and is approved for use in hospital or surgical center settings for orthopedic procedures, ensuring compliance with U.S. medical device regulations.
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 ..., Alamo® C (K173128) - FDA 510 (k), ALLIANCE PARTNERS LLC 0107-1706 Alamo C - RevMed, Alamo® C 510 (k) FDA Premarket Notification K173128 Alliance Partners, LLC
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K133321 | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K173128 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Alliance Partners Llc
- FDA Applicant
- Alliance Partners, LLC
Sources (1)
- FDA 510(k) K173128 24 fields · synced Sep 18, 2026