Identity
- Trade Name
- Rampart T FDA UDI
- Generic Name
- Vertebral body bone graft pouch FDA UDI
- Device Name
- Rampart T Trial, 9x30 FDA UDI
- Model / Reference
- 83-03-01-9 FDA UDI
- Description
- Rampart T Trial, 9x30 FDA UDI
Identifiers
- Catalog Number
- 260-0009 FDA UDI
- Primary DI / UDI-DI
- M7402600009 FDA UDI
- 510(k) Number
- K163409 FDA UDI
- FDA Product Code
- MAX FDA UDI
- GMDN Term
- Vertebral body bone graft pouch FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3080 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Rampart T by Spineology Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Spineology Inc.
Sources (1)
- FDA UDI a881e77e-4892-4a03-8439-8b45f1615c3a 37 fields · synced Jun 1, 2026