Identity
- Trade Name
- Rampart One Lumbar Interbody Fusion System FDA UDI
- Generic Name
- Surgical implant/trial-implant/sizer holder, reusable FDA UDI
- Device Name
- 15 degree Inserter Block Assembly FDA UDI
- Model / Reference
- 102-63-01-2 FDA UDI
- Description
- 15 degree Inserter Block Assembly FDA UDI
Identifiers
- Catalog Number
- 100-1335 FDA UDI
- Primary DI / UDI-DI
- M7401001335 FDA UDI
- 510(k) Number
- K192047 FDA UDI
- FDA Product Code
- OVD FDA UDI
- GMDN Term
- Surgical implant/trial-implant/sizer holder, 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
Category: Surgical implant/trial-implant/sizer holder, 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/trial-implant/sizer holder, reusable.
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- ARx — Life Spine, Inc. · Class II
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- JULIET INSTRUMENTATION — Spineart · Class II
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- TALOS® (HA) IBF — MEDITECH SPINE, LLC · Class II
- BENCOX THR System — Corentec Co., Ltd · Class II
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 |
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Manufacturer
- Manufacturer
- Spineology Inc.
Sources (1)
- FDA UDI 07a18c36-36f6-450d-8224-f727b0f10bb4 36 fields · synced Jun 8, 2026