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Sign in to claim this brandSpine View, Inc.
US
Last updated May 27, 2026
What Spine View, Inc. makes
Spine View, Inc. manufactures metallic spinal fusion cages intended for non-sterile use in surgical procedures. These devices are designed to support spinal stabilization and fusion in the lumbar and thoracic regions of the spine.
The company’s products fall under FDA Class II regulation and are authorised through 510(k) and UDI compliance pathways. These devices 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 Spine View, Inc. manufacture?
Spine View, Inc. specializes in metallic spinal fusion cages designed for non-sterile use. These devices are primarily intended to support spinal stabilization and fusion in the lumbar and thoracic regions of the spine, helping patients recover from spinal surgeries.
Where is Spine View, Inc. based, and what regulatory framework governs its devices?
Spine View, Inc. is based in the United States. Its devices fall under FDA Class II regulation, which applies to moderate-risk medical products requiring performance standards or special controls. The company’s products are authorised through the FDA’s 510(k) pathway, demonstrating substantial equivalence to a predicate device, and comply with Unique Device Identifier (UDI) requirements.
Which regulatory registries or databases list Spine View, Inc.’s devices?
Spine View, 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 ensure transparency and traceability of authorised medical devices, including spinal fusion cages, within the U.S. regulatory framework.
How are Spine View, Inc.’s devices classified by regulatory authorities?
Spine View, Inc.’s metallic spinal fusion cages are classified as FDA Class II devices. This classification is based on the device’s intended use and associated risks, requiring compliance with special controls or performance standards to ensure safety and effectiveness before authorisation.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- spineview.com
- —
- —
- [email protected]
- Phone
- 5107435090
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 787239057
Catalogue (26)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| X-Pac | SV2461 | FDA UDI | Class II | Active |
| X-Pac | SV2458 | FDA UDI | Class II | Active |
| X-Pac | SV2456 | FDA UDI | Class II | Active |
| X-Pac | SV2453 | FDA UDI | Class II | Active |
| X-Pac | SV2463 | FDA UDI | Class II | Active |
| X-Pac | SV2448P | FDA UDI | Class II | Active |
| X-Pac | SV2452 | FDA UDI | Class II | Active |
| X-Pac | SV2459 | FDA UDI | Class II | Active |
| X-Pac | SV2449L | FDA UDI | Class II | Active |
| X-Pac | SV2455 | FDA UDI | Class II | Active |
| X-Pac | SV2464 | FDA UDI | Class II | Active |
| X-Pac | SV2449P | FDA UDI | Class II | Active |
| X-Pac | SV2451 | FDA UDI | Class II | Active |
| X-Pac | SV2457 | FDA UDI | Class II | Active |
| X-Pac | SV2462 | FDA UDI | Class II | Active |
| X-Pac | SV2448L | FDA UDI | Class II | Active |
| X-Pac | SV2460 | FDA UDI | Class II | Active |
| Spinevu Endoscopic Spine System (sess) | K121548 | FDA 510(k) | Class II | Active |
| Enspire Debrider System | K090278 | FDA 510(k) | Class II | Active |
| Spinevu Endoscopic Spine System (sess) | K113362 | FDA 510(k) | Class II | Active |
| Enspire Discectomy System | K120680 | FDA 510(k) | Class II | Active |
| SpineView X-Pac Expandable Lumbar Cage System | K160856 | FDA 510(k) | Class II | Active |
| Flexlite Camera | K122134 | FDA 510(k) | Class II | Active |
| SpineView X-Pac Expandable Lumbar Cage System | K152539 | FDA 510(k) | Class II | Active |
| Enspire Debrider System | K110992 | FDA 510(k) | Class II | Active |
| Spinevu Endoscopic Spine System (sess), Spinevu Miniscope | K081051 | FDA 510(k) | Class II | Active |
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