Identifiers
- 510(k) Number
- K210590 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 Axis Spine Technologies ALIF is an anterior lumbar interbody fusion (ALIF) device designed for spinal stabilization and fusion procedures. It features a locking cap mechanism to secure screws and contain bone graft, aiding in maintaining lordotic alignment and promoting bony integration at the lumbar spine levels.
This device is intended for single-use in surgical settings and is supplied sterile. It is classified under the FDA’s product code OVD (Orthopedic Devices, Vertebral Fusion Devices) and received a Traditional 510(k) clearance via the Orthopedic (OR) Advisory Committee. The device is not MRI-safe and must be handled and stored according to manufacturer instructions to preserve sterility and structural integrity.
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: AXIS-ALIF - Axis Spine Technologies, Axis Spine | Precision Spinal Implants for Optimal Alignment, AXIS-ALIF - Axis Spine Technologies, Clinical Archives - Axis Spine Technologies
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K210590 | Class II | Active |
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Manufacturer
- Manufacturer
- Axis Spine Technologies Ltd
- FDA Applicant
- Axis Spine Technologies, Ltd.
Sources (1)
- FDA 510(k) K210590 24 fields · synced Sep 20, 2026