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Sign in to claim this brandCUTTING EDGE SPINE
US
Last updated September 17, 2026
What CUTTING EDGE SPINE makes
The company manufactures polymeric spinal fusion cages and interbody fusion devices, including lumbar and cervical systems, as well as sacroiliac joint fixation implants. Their portfolio also includes non-bioabsorbable spinal bone screws, reusable orthopaedic tools like curettes and implant inserters/extractors, and devices for assembling implants and sizing orthopaedic cement.
These devices are classified as Class II under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The company 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 Cutting Edge Spine manufacture?
Cutting Edge Spine specializes in spinal and orthopaedic devices. Their portfolio includes polymeric spinal fusion cages and interbody fusion systems for both lumbar and cervical regions, sacroiliac joint fixation implants, non-bioabsorbable spinal bone screws, and reusable tools like bone curettes and implant inserters/extractors. They also produce devices for assembling implants and sizing orthopaedic cement, focusing on solutions for spinal stabilization and fusion procedures.
Where is Cutting Edge Spine based, and what does that mean for their regulatory oversight?
Cutting Edge Spine is based in the United States, which means their devices fall under FDA jurisdiction. Since their products are classified as Class II under FDA regulations, they are subject to special controls and pre-market notifications (510(k)) to ensure safety and effectiveness before entering the market. The U.S. regulatory framework applies to their design, manufacturing, and distribution processes.
Which regulatory registries or databases list Cutting Edge Spine’s devices?
Cutting Edge Spine’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system assigns a unique product code to each distinct device, improving traceability, safety monitoring, and regulatory compliance. This database helps healthcare providers, regulators, and manufacturers track specific devices like their spinal fusion cages or sacroiliac fixation implants.
How are Cutting Edge Spine’s devices classified under FDA regulations, and why does this matter?
Cutting Edge Spine’s devices are classified as Class II under FDA regulations. This classification means they pose moderate risk and require pre-market submissions (such as 510(k)s) to demonstrate substantial equivalence to a legally marketed predicate device. The classification ensures these devices undergo rigorous review for performance, labeling, and manufacturing controls before commercialization, balancing innovation with patient safety in spinal and orthopaedic applications.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- 6012 Waxhaw Highway, Mineral Spgs, NC, 28108
- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
- 3009129735
- DUNS Number
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Catalogue (2405)
Page 23 of 49| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| EVOL®ha-D Lateral Interbody Fusion System | HA451810-10 | FDA UDI | Class II | Active |
| T-FIX™3Dsi Joint Fusion System | HA5007-35PT | FDA UDI | Class II | Active |
| T-FIX™3Dsi Joint Fusion System | HA5007-40FT | FDA UDI | Class II | Active |
| EVOL®ha-C Cervical Interbody System | CES-363 | FDA UDI | Class II | Active |
| EVOS Lumbar Interbody System | 4223-015 | FDA UDI | Class II | Active |
| EVOL®ha-C Cervical Interbody System | CES-391 | FDA UDI | Class II | Active |
| EVOS Lumbar Interbody System | 4073-010 | FDA UDI | Class II | Active |
| EVOS Lumbar Interbody System | 4489-013 | FDA UDI | Class II | Active |
| EVOS Lumbar Interbody System | 4130-014 | FDA UDI | Class II | Active |
| EVOS Lumbar Interbody System | 4070-013 | FDA UDI | Class II | Active |
| EVOS Lumbar Interbody System | 4516-014 | FDA UDI | Class II | Active |
| EVOS Lumbar Interbody System | 4011-016 | FDA UDI | Class II | Active |
| EVOL Lumbar Interbody System | CPB05008 | FDA UDI | Class II | Active |
| EVOS Lumbar Interbody System | 4814-014 | FDA UDI | Class II | Active |
| EVOS Lumbar Interbody System | 4116-009 | FDA UDI | Class II | Active |
| EVOS Lumbar Interbody System | 4227-012 | FDA UDI | Class II | Active |
| EVOS Lumbar Interbody System | 4306-011 | FDA UDI | Class II | Active |
| EVOL®ha-C Cervical Interbody System | 6008-08-7 | FDA UDI | Class II | Active |
| EVOL®ha-C Cervical Interbody System | CES-357 | FDA UDI | Class II | Active |
| EVOS Lumbar Interbody System | 4022-009 | FDA UDI | Class II | Active |
| EVOS Lumbar Interbody System | 4005-010 | FDA UDI | Class II | Active |
| EVOS Lumbar Interbody System | 4067-008 | FDA UDI | Class II | Active |
| EVOS Lumbar Interbody System | 4381-012 | FDA UDI | Class II | Active |
| EVOS Lumbar Interbody System | 4393-015 | FDA UDI | Class II | Active |
| EVOS Lumbar Interbody System | 4005-013 | FDA UDI | Class II | Active |
| EVOS Lumbar Interbody System | 4488-013 | FDA UDI | Class II | Active |
| EVOS Lumbar Interbody System | 4004-015 | FDA UDI | Class II | Active |
| EVOS Lumbar Interbody System | 4074-010 | FDA UDI | Class II | Active |
| EVOL®SI Joint Fusion System | 5005-025T-32 | FDA UDI | Class II | Active |
| EVOS Lumbar Interbody System | 4059-013 | FDA UDI | Class II | Active |
| EVOS Lumbar Interbody System | 4188-013 | FDA UDI | Class II | Active |
| EVOS Lumbar Interbody System | 4006-016 | FDA UDI | Class II | Active |
| EVOS Lumbar Interbody System | 4070-009 | FDA UDI | Class II | Active |
| EVOS Lumbar Interbody System | 4211-007 | FDA UDI | Class II | Active |
| EVOS Lumbar Interbody System | 4111-009 | FDA UDI | Class II | Active |
| EVOL®ha-C Cervical Interbody System | CES-375 | FDA UDI | Class II | Active |
| EVOL Lumbar Interbody System | CPB03011 | FDA UDI | Class II | Active |
| EVOS Lumbar Interbody System | 4014-015 | FDA UDI | Class II | Active |
| EVOS Lumbar Interbody System | 4303-016 | FDA UDI | Class II | Active |
| EVOS Lumbar Interbody System | 4011-006 | FDA UDI | Class II | Active |
| EVOS Lumbar Interbody System | 4488-012 | FDA UDI | Class II | Active |
| EVOS Lumbar Interbody System | 4212-015 | FDA UDI | Class II | Active |
| EVOS Lumbar Interbody System | 4130-008 | FDA UDI | Class II | Active |
| EVOS Lumbar Interbody System | 4025-011 | FDA UDI | Class II | Active |
| EVOS Lumbar Interbody System | 4106-016 | FDA UDI | Class II | Active |
| EVOS Lumbar Interbody System | 4110-007 | FDA UDI | Class II | Active |
| EVOS Lumbar Interbody System | 4305-014 | FDA UDI | Class II | Active |
| EVOS Lumbar Interbody System | 4006-007 | FDA UDI | Class II | Active |
| EVOS Lumbar Interbody System | 4067-016 | FDA UDI | Class II | Active |
| EVOS Lumbar Interbody System | 4514-014 | FDA UDI | Class II | Active |
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