Rampart™ One Lumbar Interbody Fusion System

Intervertebral Fusion Device With Integrated Fixation, Lumbar

Spineology, Inc.

The following data is part of a premarket notification filed by Spineology, Inc. with the FDA for Rampart™ One Lumbar Interbody Fusion System.

Pre-market Notification Details

• Device ID: K192047
• 510k Number: K192047
• Device Name: Rampart™ One Lumbar Interbody Fusion System
• Classification: Intervertebral Fusion Device With Integrated Fixation, Lumbar
• Applicant: Spineology, Inc. 7800 3rd Street North, Suite 600 Saint Paul, MN 55128
• Contact: Andrew Adams
• Correspondent: Andrew Adams; Spineology, Inc. 7800 3rd Street North, Suite 600 Saint Paul, MN 55128
• Product Code: OVD
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-07-31
• Decision Date: 2019-08-23

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
M7404902033	K192047	000
M7404901611	K192047	000
M7404901610	K192047	000
M7404901609	K192047	000
M7404901608	K192047	000
M7404901607	K192047	000
M7404901410	K192047	000
M7404901409	K192047	000
M7404901408	K192047	000
M7404901407	K192047	000
M7404901612	K192047	000
M7404901817	K192047	000
M7404902032	K192047	000
M7404902031	K192047	000
M7404902030	K192047	000
M7404902029	K192047	000
M7404901822	K192047	000
M7404901821	K192047	000
M7404901820	K192047	000
M7404901819	K192047	000
M7404901818	K192047	000
M7404900005	K192047	000