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Rampart One Lumbar Interbody Fusion System

FDA UDI

Class I (US FDA UDI)

by Spineology Inc.

Identity

Trade Name
Rampart One Lumbar Interbody Fusion System FDA UDI
Generic Name
Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI
Device Name
Oblique Inserter FDA UDI
Model / Reference
46-03-01 FDA UDI
Description
Oblique Inserter FDA UDI

Identifiers

Catalog Number
460-0001 FDA UDI
Primary DI / UDI-DI
M7404600001 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Orthopaedic inorganic implant inserter/extractor, reusable

Rampart One Lumbar Interbody Fusion System by Spineology Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic inorganic implant inserter/extractor, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Spineology Inc.

Sources (1)

  • FDA UDI 5ffd027c-5afa-4576-8e40-a6825f5ac1a4 35 fields · synced Jun 8, 2026