Identifiers
- 510(k) Number
- K222561 FDA 510(k)
- FDA Product Code
- OVD 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 Align ALIF is an anterior lumbar interbody fusion device designed for spinal stabilization. It is a spinal implant intended to facilitate bone in-growth and promote fusion between vertebrae in the lumbar spine, offering both two-screw and four-screw configurations to accommodate varying surgical needs. This device is classified under orthopedic spinal instrumentation and is intended for use in anterior lumbar interbody fusion procedures.
The Align ALIF is supplied as a stand-alone device and is implanted through a single incision, minimizing surgical trauma. It is intended for single-use and is regulated under FDA 510(k) clearance (K222561) as a substantially equivalent orthopedic device. The device is available in multiple footprints and screw configurations to enhance flexibility in surgical applications. Storage and handling follow standard sterile medical device protocols as per manufacturer guidelines.
Frequently asked questions
What is the Align ALIF device used for?
The Align ALIF is an anterior lumbar interbody fusion (ALIF) device intended to stabilize the lumbar spine by facilitating bone in-growth and promoting fusion between vertebrae. It is specifically designed for spinal stabilization in ALIF procedures, where it bridges gaps between adjacent lumbar vertebrae to restore structural integrity and mobility.
How is the Align ALIF supplied and implanted?
The Align ALIF is supplied as a standalone device and is implanted through a single incision, which helps minimize surgical trauma. Its design allows for straightforward placement during anterior lumbar interbody fusion procedures, reducing the complexity of the surgery compared to multi-incision approaches.
Is the Align ALIF device single-use or reusable?
The Align ALIF is intended for single-use only. This aligns with standard medical device practices to ensure sterility and patient safety, as reusable devices require rigorous cleaning and sterilization protocols that may not be feasible or safe for implants.
What configurations are available for the Align ALIF?
The Align ALIF offers flexibility in surgical applications through multiple footprints and screw configurations, including two-screw and four-screw options. These variations allow surgeons to select the optimal setup based on the patient’s anatomy and specific clinical needs, ensuring a tailored fit for lumbar stabilization.
How should the Align ALIF be stored and handled?
The Align ALIF must be stored and handled according to standard sterile medical device protocols as outlined by the manufacturer. Proper storage ensures the device remains uncontaminated and ready for use, adhering to best practices for orthopedic implants to maintain integrity and sterility until implantation.
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: Home - Acuity Surgical, Align ALIF - Acuity Surgical, ACUITY SURGICAL DEVICES, LLC 12-32211520 Align, K222561 FDA 510 (k) - Align | Acuity Surgical Devices, LLC
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K222561 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Acuity Surgical Devices, Llc
Sources (1)
- FDA 510(k) K222561 24 fields · synced Oct 1, 2026