Identity
- Trade Name
- Rampart O FDA UDI
- Generic Name
- Vertebral body bone graft pouch FDA UDI
- Device Name
- 8x30mm Trial FDA UDI
- Model / Reference
- 83-04-07-18 FDA UDI
- Description
- 8x30mm Trial FDA UDI
Identifiers
- Catalog Number
- 280-0012 FDA UDI
- Primary DI / UDI-DI
- M7402800012 FDA UDI
- 510(k) Number
- K160906 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
- 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
Dimensions & Sizes
- Size
- Height — 8 Millimeter FDA UDI
Category: Vertebral body bone graft pouch
Rampart O by Spineology Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Vertebral body bone graft pouch.
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Cleared under the same submission
K160906 also covers:
- Rampart O — SPINEOLOGY INC.
- Rampart O — SPINEOLOGY INC.
- Rampart O — SPINEOLOGY INC.
- Rampart O — SPINEOLOGY INC.
- Rampart O — SPINEOLOGY INC.
- Rampart O — SPINEOLOGY INC.
- Rampart O — SPINEOLOGY INC.
- Rampart O — SPINEOLOGY INC.
- Rampart O — SPINEOLOGY INC.
- Rampart O — SPINEOLOGY INC.
- Rampart O — SPINEOLOGY INC.
- Rampart O — SPINEOLOGY INC.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Spineology Inc.
Sources (1)
- FDA UDI 6e384330-e10b-41d4-b1db-d4cfe64f5341 37 fields · synced May 30, 2026