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Sign in to claim this brandNovapproach Spine
US
Last updated May 23, 2026
What Novapproach Spine makes
The company designs and manufactures metallic spinal interbody fusion cages, spinal bone screws made from non-bioabsorbable materials, and reusable internal spinal fixation procedure kits. These products are intended for spinal stabilization and fusion procedures, including trial applications for surgical planning.
All listed devices fall under Class II regulatory classification in the US, with authorisation obtained through FDA 510(k) submissions and inclusion in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Novapproach Spine manufacture?
Novapproach Spine specializes in metallic spinal devices used for stabilization and fusion procedures. Their primary products include metallic spinal interbody fusion cages, non-bioabsorbable spinal bone screws, and reusable internal spinal fixation procedure kits. These devices are designed to support surgical interventions, including trial applications for preoperative planning.
Where is Novapproach Spine based?
Novapproach Spine is headquartered in the United States. The company’s location is relevant for understanding its regulatory framework, as its devices are authorised under US regulations.
Which regulatory registries or databases list Novapproach Spine’s devices?
Novapproach Spine’s devices are included in the FDA’s 510(k) premarket notification submissions and the FDA’s Unique Device Identifier (UDI) database. These registries confirm the devices’ compliance with US regulatory requirements for Class II medical devices.
How are Novapproach Spine’s devices classified under US regulations?
All of Novapproach Spine’s listed devices fall under Class II regulatory classification in the US. This classification applies to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as spinal implants and fixation systems.
What is the significance of the OneLIF™ product line in Novapproach Spine’s offerings?
The OneLIF™ product line represents the core of Novapproach Spine’s portfolio, encompassing multiple device types—including interbody fusion cages, spinal screws, and fixation kits—all designed for spinal stabilization and fusion. Since all listed examples are OneLIF™ variants, this line demonstrates the company’s focus on reusable and metallic solutions for spinal surgery.
AI-generated from registry data and not verified by a human reviewer.
Information
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- US
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Catalogue (225)
Page 1 of 5| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| OneLIF™ | 011-113-1410 | FDA UDI | Class II | Active |
| OneLIF™ | 013-321-1122 | FDA UDI | Class II | Active |
| OneLIF™ | 013-100-1000 | FDA UDI | Class II | Active |
| OneLIF™ | 015-025-0000 | FDA UDI | Class II | Active |
| OneLIF™ | 011-107-1411 | FDA UDI | Class II | Active |
| OneLIF™ | 013-100-1218 | FDA UDI | Class II | Active |
| OneLIF™ | 013-230-1220 | FDA UDI | Class II | Active |
| OneLIF™ | 010-125-1606 | FDA UDI | Class II | Active |
| OneLIF™ | 012-001-4524 | FDA UDI | Class II | Active |
| OneLIF™ | 013-131-1218 | FDA UDI | Class II | Active |
| OneLIF™ | 011-125-1808 | FDA UDI | Class II | Active |
| OneLIF™ | 015-026-0000 | FDA UDI | Class II | Active |
| OneLIF™ | 010-207-1007 | FDA UDI | Class II | Active |
| OneLIF™ | 015-018-0000 | FDA UDI | Class II | Active |
| OneLIF™ | 015-017-0000 | FDA UDI | Class II | Active |
| OneLIF™ | 010-125-1808 | FDA UDI | Class II | Active |
| OneLIF™ | 013-210-1000 | FDA UDI | Class II | Active |
| OneLIF™ | 010-113-1410 | FDA UDI | Class II | Active |
| OneLIF™ | 015-022-0000 | FDA UDI | Class II | Active |
| OneLIF™ | 015-040-0000 | FDA UDI | Class II | Active |
| OneLIF™ | 011-913-1208 | FDA UDI | Class II | Active |
| OneLIF™ | 010-213-1610 | FDA UDI | Class II | Active |
| OneLIF™ | SPX-011-613-1107 | FDA UDI | Class II | Active |
| OneLIF™ | 012-001-4024 | FDA UDI | Class II | Active |
| OneLIF™ | 012-001-4516 | FDA UDI | Class II | Active |
| OneLIF™ | 012-005-4720 | FDA UDI | Class II | Active |
| OneLIF™ | 010-313-1205 | FDA UDI | Class II | Active |
| OneLIF™ | 014-000-0000 | FDA UDI | Class II | Active |
| OneLIF™ | 011-107-1209 | FDA UDI | Class II | Active |
| OneLIF™ | 010-107-1007-2 | FDA UDI | Class II | Active |
| OneLIF™ | 013-311-1222 | FDA UDI | Class II | Active |
| OneLIF™ | 011-313-2013 | FDA UDI | Class II | Active |
| OneLIF™ | 015-028-0000 | FDA UDI | Class II | Active |
| OneLIF™ | 012-001-4528 | FDA UDI | Class II | Active |
| OneLIF™ | 013-321-1222 | FDA UDI | Class II | Active |
| OneLIF™ | 010-119-1407 | FDA UDI | Class II | Active |
| OneLIF™ | 010-319-1606 | FDA UDI | Class II | Active |
| OneLIF™ | 011-225-1807 | FDA UDI | Class II | Active |
| OneLIF™ | 013-111-1218 | FDA UDI | Class II | Active |
| OneLIF™ | 011-307-1612 | FDA UDI | Class II | Active |
| OneLIF™ | 011-213-1408 | FDA UDI | Class II | Active |
| OneLIF™ | 011-613-0004 | FDA UDI | Class II | Active |
| OneLIF™ | 012-003-4016 | FDA UDI | Class II | Active |
| OneLIF™ | 010-319-1808 | FDA UDI | Class II | Active |
| OneLIF™ | 010-225-2009 | FDA UDI | Class II | Active |
| OneLIF™ | 010-113-1006-2 | FDA UDI | Class II | Active |
| OneLIF™ | 013-300-1000 | FDA UDI | Class II | Active |
| OneLIF™ | 013-330-1222 | FDA UDI | Class II | Active |
| OneLIF™ | 012-003-4528 | FDA UDI | Class II | Active |
| OneLIF™ | 011-113-1006 | FDA UDI | Class II | Active |
Related Companies
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FDA Recalls (2)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Apr 23, 2026 | Z-2213-2026 | — | open, classified | Intervertebral body fusion system straight inserter failed to properly attach to affected cages, which may result in an inability to securely engage the implant with the inserter, which could lead to procedural delay and/or the need to select an alternative implant. |
| Oct 12, 2022 | Z-0246-2023 | — | terminated | The torque limiting adapter may not stay locked inside of the ratcheting handle once fully engaged. |