Identity
- Trade Name
- Ventura NanoMetalene System FDA UDI
- Generic Name
- Vertebral body prosthesis FDA UDI
- Device Name
- Ventura NM Implant, 11mm x 20mm x 17mm FDA UDI
- Model / Reference
- 33-6117 FDA UDI
- Description
- Ventura NM Implant, 11mm x 20mm x 17mm FDA UDI
Identifiers
- Catalog Number
- 33-6117 FDA UDI
- Primary DI / UDI-DI
- 10889981150280 FDA UDI
- 510(k) Number
- K173022 FDA UDI
- FDA Product Code
- MAX FDA UDI
- GMDN Term
- Vertebral body prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3080 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Vertebral body prosthesis
Ventura NanoMetalene System by SeaSpine Orthopedics Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Vertebral body prosthesis.
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Cleared under the same submission
K173022 also covers:
- Ventura NanoMetalene System — SeaSpine Orthopedics Corporation
- Ventura NanoMetalene System — SeaSpine Orthopedics Corporation
- Ventura NanoMetalene System — SeaSpine Orthopedics Corporation
- Ventura NanoMetalene System — SeaSpine Orthopedics Corporation
- Ventura NanoMetalene System — SeaSpine Orthopedics Corporation
- Ventura NanoMetalene System — SeaSpine Orthopedics Corporation
- Ventura NanoMetalene System — SeaSpine Orthopedics Corporation
- Ventura NanoMetalene System — SeaSpine Orthopedics Corporation
- Ventura NanoMetalene System — SeaSpine Orthopedics Corporation
- Ventura NanoMetalene System — SeaSpine Orthopedics Corporation
- Ventura NanoMetalene System — SeaSpine Orthopedics Corporation
- Ventura NanoMetalene System — SeaSpine Orthopedics Corporation
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- SeaSpine Orthopedics Corporation
Sources (1)
- FDA UDI 80170e72-d9a7-4374-bcf3-8bb41b37674c 37 fields · synced Jun 8, 2026