Identity
- Trade Name
- Rampart One Lumbar Interbody Fusion System FDA UDI
- Generic Name
- Surgical implant template, reusable FDA UDI
- Device Name
- Trial 12mm M 8° FDA UDI
- Model / Reference
- 102-63-06-7 FDA UDI
- Description
- Trial 12mm M 8° FDA UDI
Identifiers
- Catalog Number
- 100-1314 FDA UDI
- Primary DI / UDI-DI
- M7401001314 FDA UDI
- 510(k) Number
- K192047 FDA UDI
- FDA Product Code
- OVD FDA UDI
- GMDN Term
- Surgical implant template, reusable 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
No
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 — 12 Millimeter FDA UDIAngle — 8 degree FDA UDI
Category: Surgical implant template, reusable
Rampart One Lumbar Interbody Fusion System by Spineology Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical implant template, reusable.
- Newclip Instruments — NEWCLIP TECHNICS · Class I
- Titan Reverse Shoulder System — Smith & Nephew, Inc. · Class I
- Legion — Smith & Nephew, Inc. · Class II
- LIGAFIX® — S.B.M. SAS · Class I
- EVOS — Smith & Nephew, Inc. · Class I
- Tranquil-C™ — NEXUS SPINE, L.L.C. · Class I
- VFT — Ldr Spine USA · Class II
- Tranquil-C™ — NEXUS SPINE, L.L.C. · Class I
Cleared under the same submission
K192047 also covers:
- Rampart One Lumbar Interbody Fusion System — SPINEOLOGY INC.
- Rampart One Lumbar Interbody Fusion System — SPINEOLOGY INC.
- Rampart One Lumbar Interbody Fusion System — SPINEOLOGY INC.
- Rampart One Lumbar Interbody Fusion System — SPINEOLOGY INC.
- Rampart One Lumbar Interbody Fusion System — SPINEOLOGY INC.
- Rampart One Lumbar Interbody Fusion System — SPINEOLOGY INC.
- Rampart One Lumbar Interbody Fusion System — SPINEOLOGY INC.
- Rampart One Lumbar Interbody Fusion System — SPINEOLOGY INC.
- Rampart One Lumbar Interbody Fusion System — SPINEOLOGY INC.
- Rampart One Lumbar Interbody Fusion System — SPINEOLOGY INC.
- Rampart One Lumbar Interbody Fusion System — SPINEOLOGY INC.
- Rampart One Lumbar Interbody Fusion System — 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 a40a9d15-2f79-4a67-bb07-53262e948b68 37 fields · synced May 30, 2026