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Sign in to claim this brandSpineex, Inc.
US
Last updated May 27, 2026
What Spineex, Inc. makes
Spineex, Inc. manufactures reusable orthopaedic surgical instruments, including torque-limiting handle systems, implant inserters, and extractors designed for spinal procedures. Their portfolio also includes metallic spinal interbody fusion cages, graft inserters, and reusable instrument trays, alongside specialized tools like bone graft funnels for spinal surgeries.
All devices are classified as Class II under FDA regulations and are authorised through the 510(k) and Unique Device Identifier (UDI) pathways. The company’s products are listed in the FDA’s regulatory databases, and the manufacturer is based in 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 Spineex, Inc. manufacture?
Spineex, Inc. specializes in reusable orthopaedic surgical instruments and spinal implants. Their product range includes torque-limiting handle systems for surgical precision, implant inserters and extractors for spinal procedures, metallic spinal interbody fusion cages, reusable instrument trays, and specialized tools like bone graft funnels. These devices are designed to support spinal surgeries and orthopaedic interventions.
Where is Spineex, Inc. based?
Spineex, Inc. is headquartered in the United States. The company’s location is relevant for understanding its regulatory framework, as it operates under FDA guidelines for device authorization.
How are Spineex, Inc.’s devices classified under FDA regulations?
All devices manufactured by Spineex, Inc. fall under Class II classification according to FDA regulations. This classification typically applies to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as surgical instruments and spinal implants.
Which regulatory registries or databases list Spineex, Inc.’s devices?
Spineex, Inc.’s devices are listed in the FDA’s 510(k) premarket notification database and the FDA’s Unique Device Identifier (UDI) system. These registries confirm that the devices have undergone the required authorization pathways (510(k) clearance or UDI compliance) before entering the market.
Why are Spineex, Inc.’s devices authorized through the 510(k) and UDI pathways?
The 510(k) pathway demonstrates that Spineex’s devices are substantially equivalent to legally marketed predicates, meeting FDA’s criteria for safety and performance. The UDI system ensures traceability and transparency in the supply chain by assigning a unique identifier to each device, aiding in post-market surveillance and recall management. Both pathways are standard for Class II devices requiring regulatory oversight.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- spineexinc.com
- —
- —
- [email protected]
- Phone
- 5105736165
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 080723590
Catalogue (55)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Sagittae | 902-030-03 | FDA UDI | Class II | Active |
| Sagittae | 902-030-11 | FDA UDI | Class II | Active |
| Sagittae | 025-030-10 | FDA UDI | Class II | Active |
| Sagittae | 010-030-54 | FDA UDI | Class II | Active |
| Sagittae | 902-030-14 | FDA UDI | Class II | Active |
| Sagittae | 025-030-07 | FDA UDI | Class II | Active |
| Sagittae | 025-030-14 | FDA UDI | Class II | Active |
| Sagittae | 901-030-02 | FDA UDI | Class II | Active |
| Sagittae | 502-030-23 | FDA UDI | Class II | Active |
| Sagittae | 012-030-11 | FDA UDI | Class II | Active |
| Sagittae | 901-030-00 | FDA UDI | Class II | Active |
| Sagittae | 025-030-05 | FDA UDI | Class II | Active |
| Sagittae | 502-030-26 | FDA UDI | Class II | Active |
| Sagittae | 502-030-14 | FDA UDI | Class II | Active |
| Sagittae | 902-030-12 | FDA UDI | Class II | Active |
| Sagittae | 013-030-11 | FDA UDI | Class II | Active |
| Sagittae | 025-030-12 | FDA UDI | Class II | Active |
| Sagittae | 010-030-58 | FDA UDI | Class II | Active |
| Sagittae | 025-030-09 | FDA UDI | Class II | Active |
| Sagittae | 013-030-01 | FDA UDI | Class II | Active |
| Sagittae | 010-030-50 | FDA UDI | Class II | Active |
| Sagittae | 075-030-00 | FDA UDI | Class II | Active |
| Sagittae | 076-030-00 | FDA UDI | Class II | Active |
| Sagittae | 025-030-16 | FDA UDI | Class II | Active |
| Sagittae | 025-030-08 | FDA UDI | Class II | Active |
| Sagittae | 902-030-13 | FDA UDI | Class II | Active |
| Sagittae | 014-030-22 | FDA UDI | Class II | Active |
| Sagittae | 903-030-XX | FDA UDI | Class II | Active |
| Sagittae | 025-030-15 | FDA UDI | Class II | Active |
| Sagittae | 901-030-03 | FDA UDI | Class II | Active |
| Sagittae | 025-030-13 | FDA UDI | Class II | Active |
| Sagittae | 902-030-10 | FDA UDI | Class II | Active |
| Sagittae | 521-030-00 | FDA UDI | Class II | Active |
| Sagittae | 010-030-42 | FDA UDI | Class II | Active |
| Sagittae | 025-030-11 | FDA UDI | Class II | Active |
| Sagittae | 902-030-05 | FDA UDI | Class II | Active |
| Sagittae | 075-030-10 | FDA UDI | Class II | Active |
| Sagittae | 012-030-10 | FDA UDI | Class II | Active |
| Sagittae | 901-030-04 | FDA UDI | Class II | Active |
| Sagittae | 902-030-04 | FDA UDI | Class II | Active |
| Sagittae | 902-030-15 | FDA UDI | Class II | Active |
| Sagittae | 012-030-20 | FDA UDI | Class II | Active |
| Sagittae | 902-030-02 | FDA UDI | Class II | Active |
| Sagittae | 502-030-13 | FDA UDI | Class II | Active |
| Sagittae | 902-030-01 | FDA UDI | Class II | Active |
| Sagittae | 012-030-21 | FDA UDI | Class II | Active |
| Sagittae | 902-030-00 | FDA UDI | Class II | Active |
| Sagittae | 901-030-01 | FDA UDI | Class II | Active |
| Sagittae | 010-030-46 | FDA UDI | Class II | Active |
| Sagittae | 012-030-00 | FDA UDI | Class II | Active |
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