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Sign in to claim this brandINTELLIGENT IMPLANT SYSTEMS, LLC
US
Last updated May 27, 2026
What INTELLIGENT IMPLANT SYSTEMS, LLC makes
Intelligent Implant Systems, LLC produces sterile bone-screw internal spinal fixation systems designed for spinal stabilization, including anterior cervical plates for cervical spine surgery. Their portfolio also includes non-bioabsorbable spinal fixation plates intended for internal fixation of spinal segments.
These devices are classified as Class II under FDA regulations and are authorised through the 510(k) and UDI pathways. The company is based in the United States and its products are listed in the FDA’s regulatory databases.
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 Intelligent Implant Systems, LLC manufacture?
Intelligent Implant Systems, LLC specializes in spinal fixation devices, including sterile bone-screw internal spinal fixation systems and non-bioabsorbable spinal fixation plates. These products are primarily used for spinal stabilization, such as the Mediant Anterior Cervical Plate and the REVOLUTION SPINAL SYSTEM, which are designed for cervical spine surgery and internal fixation of spinal segments.
Where is Intelligent Implant Systems, LLC based?
The company is headquartered in the United States. This location aligns with its regulatory focus on FDA compliance for its spinal fixation devices.
Which regulatory registries list Intelligent Implant Systems, LLC’s devices?
Intelligent Implant Systems, LLC’s devices are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) databases. These registries track devices authorised through the 510(k) pathway and ensure traceability via UDIs, which are required for Class II devices like those produced by the company.
How are Intelligent Implant Systems, LLC’s devices classified under FDA regulations?
The company’s devices, including bone-screw internal spinal fixation systems and non-bioabsorbable spinal fixation plates, fall under Class II classification by the FDA. This classification applies to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as premarket notifications (510(k)) and UDI compliance.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- intelligentimplantsystems.com
- —
- —
- [email protected]
- Phone
- 704-424-1009
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 013742030
Catalogue (124)
Page 3 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Mediant Anterior Cervical Plate | 12103063 | FDA UDI | Class II | Active |
| Mediant Anterior Cervical Plate | 12103072 | FDA UDI | Class II | Active |
| Mediant Anterior Cervical Plate | 12103054 | FDA UDI | Class II | Active |
| Mediant Anterior Cervical Plate | 12101036 | FDA UDI | Class II | Active |
| Mediant Anterior Cervical Plate | 1214014 | FDA UDI | Class II | Active |
| Revolution Spinal System | 1165525TL | FDA UDI | Class II | Active |
| Revolution | 1162025S | FDA UDI | Class II | Active |
| Revolution Spinal System | 1162530UC | FDA UDI | Class II | Active |
| Revolution | 11655454 | FDA UDI | Class II | Active |
| Revolution | 11655504 | FDA UDI | Class II | Active |
| Revolution | 11645354 | FDA UDI | Class II | Active |
| Revolution Spinal System | 1165555TL | FDA UDI | Class II | Active |
| Revolution Spinal System | 1167545TL | FDA UDI | Class II | Active |
| Revolution Spinal System | 1166530TL | FDA UDI | Class II | Active |
| Mediant Anterior Cervical Plate | 12102055 | FDA UDI | Class II | Active |
| Mediant Anterior Cervical Plate | 1214018 | FDA UDI | Class II | Active |
| Mediant Anterior Cervical Plate | 12103066 | FDA UDI | Class II | Active |
| Mediant Anterior Cervical Plate | 12102037 | FDA UDI | Class II | Active |
| Revolution Spinal Fixation System | K160216 | FDA 510(k) | Class II | Active |
| Active Screw Bone Screw | K121682 | FDA 510(k) | Class II | Active |
| Revolution™ Spinal Fixation System | K163056 | FDA 510(k) | Class II | Active |
| Marauder Cervical-Thoracic Spinal Fixation System | K132900 | FDA 510(k) | Class II | Active |
| Mediant Anterior Cervical Plating System | K173935 | FDA 510(k) | Class II | Active |
| Revolution Spinal Fixation System | K142939 | FDA 510(k) | Class II | Active |
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