Identity
- Trade Name
- Vu a POD Prime NanoMetalene FDA UDI
- Generic Name
- Vertebral body prosthesis FDA UDI
- Device Name
- Prime NM Implant, 39x27mm x 16mm, 25 Deg FDA UDI
- Model / Reference
- 35-97-1625 FDA UDI
- Description
- Prime NM Implant, 39x27mm x 16mm, 25 Deg FDA UDI
Identifiers
- Catalog Number
- 35-97-1625 FDA UDI
- Primary DI / UDI-DI
- 10889981159627 FDA UDI
- 510(k) Number
- K162351 FDA UDI
- FDA Product Code
- OVD 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
Vu a POD Prime NanoMetalene by SeaSpine Orthopedics Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K162351 also covers:
- Vu a POD Prime NanoMetalene — SeaSpine Orthopedics Corporation
- Vu a POD Prime NanoMetalene — SeaSpine Orthopedics Corporation
- Vu a POD Prime NanoMetalene — SeaSpine Orthopedics Corporation
- Vu a POD Prime NanoMetalene — SeaSpine Orthopedics Corporation
- Vu a-POD Prime NanoMetalene — SeaSpine Orthopedics Corporation
- Vu a-POD Prime NanoMetalene — SeaSpine Orthopedics Corporation
- Vu a-POD Prime NanoMetalene — SeaSpine Orthopedics Corporation
- Vu a-POD Prime NanoMetalene — SeaSpine Orthopedics Corporation
- Vu a-POD Prime NanoMetalene — SeaSpine Orthopedics Corporation
- Vu a-POD Prime NanoMetalene — SeaSpine Orthopedics Corporation
- Vu a-POD Prime NanoMetalene — SeaSpine Orthopedics Corporation
- Vu a-POD Prime NanoMetalene — 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 c3fc8103-8360-4cd0-8360-3fd0a7539185 37 fields · synced Jun 8, 2026