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Sign in to claim this brandBENVENUE MEDICAL, INC.
US
Last updated May 27, 2026
What BENVENUE MEDICAL, INC. makes
Benvenue Medical, Inc. manufactures polymeric spinal fusion cages that are sterile and designed for use in spinal procedures. The company also produces bone access cannulas, bone access channel kits, bone graft delivery kits, vertebral bone biopsy procedure kits (single-use), orthopaedic cement (non-antimicrobial), orthopaedic cement injection cannulas, and orthopaedic cement preparation/delivery kits.
These devices are classified as Class I and Class II medical devices and are listed in the FDA 510(k) database and the FDA UDI system. 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 Benvenue Medical, Inc. manufacture?
Benvenue Medical, Inc. manufactures polymeric spinal fusion cages that are sterile, bone access cannulas, bone access channel kits, bone graft delivery kits, vertebral bone biopsy procedure kits (single-use), orthopaedic cement (non-antimicrobial), orthopaedic cement injection cannulas, and orthopaedic cement preparation/delivery kits. These products are designed for use in spinal and orthopaedic procedures, with the polymeric spinal fusion cage being the most commonly listed device category.
Where is Benvenue Medical, Inc. based?
Benvenue Medical, Inc. is based in the United States, as explicitly stated in the provided device data under the COUNTRY field. The company’s location is confirmed in the SUMMARY section, which notes that the company operates within the U.S. regulatory environment.
In which regulatory registries are Benvenue Medical, Inc.'s devices listed?
Benvenue Medical, Inc.'s devices are listed in the FDA 510(k) database and the FDA UDI (Unique Device Identification) system, as specified in the LISTED IN field. These registries are used to track and authorize medical devices marketed in the United States, and the company’s inclusion in them reflects that individual devices have undergone the appropriate regulatory pathways for market entry.
How are Benvenue Medical, Inc.'s devices classified under U.S. regulatory standards?
Benvenue Medical, Inc.'s devices are classified as Class I and Class II medical devices, as indicated in the DEVICE CLASSES field. This classification reflects the level of regulatory control required to ensure safety and effectiveness, with Class I devices subject to general controls and Class II devices requiring special controls in addition to general controls. The classification is based on the intended use and risk profile of the devices, such as spinal fusion cages and bone access tools.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- benvenuemedical.com
- —
- —
- [email protected]
- Phone
- (800) 997-7463
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 787732689
Catalogue (52)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Kiva | KIV2150 | FDA UDI | Class II | Active |
| Luna 3D | LUN4000 | FDA UDI | Class I | Active |
| Luna 3D | LUN3014-08 | FDA UDI | Class II | Active |
| Kiva | ACC1520 | FDA UDI | Class I | Active |
| Kiva | MS3101 | FDA UDI | Class II | Active |
| Kiva | KIV2200 | FDA UDI | Class II | Active |
| Luna 3D | LUN3010 | FDA UDI | Class II | Active |
| Kiva | KIV2100 | FDA UDI | Class II | Active |
| Kiva | PLT1900 | FDA UDI | Class I | Active |
| Kiva | ACC5350 | FDA UDI | Class I | Active |
| Kiva | ACC5260 | FDA UDI | Class I | Active |
| Kiva | PLT1910 | FDA UDI | Class I | Active |
| Blazer | VAK1700 | FDA UDI | Class II | Active |
| Kiva | ACC5240 | FDA UDI | Class I | Active |
| Luna 3D | LUN3011 | FDA UDI | Class II | Active |
| Luna 3D | LUN3013 | FDA UDI | Class II | Active |
| Kiva | ACC5250 | FDA UDI | Class I | Active |
| Kiva | ACC1510 | FDA UDI | Class I | Active |
| Kiva | FRS2100 | FDA UDI | Class II | Active |
| Luna 3D | LUN3008 | FDA UDI | Class II | Active |
| Kiva | ACC5230 | FDA UDI | Class I | Active |
| Blazer | ACC3130 | FDA UDI | Class I | Active |
| Kiva | KIV2250 | FDA UDI | Class II | Active |
| Luna 3D | LUN3015-08 | FDA UDI | Class II | Active |
| Luna 3D | LUN4001 | FDA UDI | Class I | Active |
| Blazer | BCN3120 | FDA UDI | Class I | Active |
| Luna 3D | LUN3012-08 | FDA UDI | Class II | Active |
| Luna 3D | LUN3012 | FDA UDI | Class II | Active |
| Luna 3D | LUN3011-08 | FDA UDI | Class II | Active |
| Luna 3D | LUN3009 | FDA UDI | Class II | Active |
| Kiva | FRS2200 | FDA UDI | Class II | Active |
| Kiva | VAK1800 | FDA UDI | Class II | Active |
| Luna 3D | LUN4200 | FDA UDI | Class I | Active |
| Luna 3D | LUN3013-08 | FDA UDI | Class II | Active |
| Kiva | MS3643 | FDA UDI | Class I | Active |
| Luna 3D | LUN3010-08 | FDA UDI | Class II | Active |
| Blazer | ACC3140 | FDA UDI | Class I | Active |
| Blazer | ACC3150 | FDA UDI | Class I | Active |
| Blazer | MS2079 | FDA UDI | Class II | Active |
| Kiva | ACC5225 | FDA UDI | Class I | Active |
| Kiva | ACC5220 | FDA UDI | Class I | Active |
| Kiva | ACC5270 | FDA UDI | Class I | Active |
| Blazer | ACC3120 | FDA UDI | Class I | Active |
| Blazer | BZK3130 | FDA UDI | Class I | Active |
| Luna Interbody System | K142023 | FDA 510(k) | Class II | Active |
| Trivergent Spinal Fixation System | K201427 | FDA 510(k) | Class II | Active |
| Kiva Vcf Treatment System | K141141 | FDA 510(k) | Class II | Active |
| Luna XD Ti Interbody Fusion System | K193172 | FDA 510(k) | Class II | Active |
| Benvenue Vcf Osteo Coil System | K070293 | FDA 510(k) | Class I | Active |
| Luna 3D Interbody Fusion System | K162431 | FDA 510(k) | Class II | Active |
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