OneLIF Intervertebral Body Replacement System

Intervertebral Fusion Device With Integrated Fixation, Lumbar

NovApproach Spine

The following data is part of a premarket notification filed by Novapproach Spine with the FDA for Onelif Intervertebral Body Replacement System.

Pre-market Notification Details

• Device ID: K211769
• 510k Number: K211769
• Device Name: OneLIF Intervertebral Body Replacement System
• Classification: Intervertebral Fusion Device With Integrated Fixation, Lumbar
• Applicant: NovApproach Spine 13900 Tech City Circle, Suite 300 Alachua, FL 32615
• Contact: Ronald P. Green
• Correspondent: Meredith Lee May; Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, CO 80918
• Product Code: OVD
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-06-08
• Decision Date: 2021-09-07
• Summary: summary

NIH GUDID Devices

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