Aprevo® Anterior And Lateral Lumbar Interbody Fusion Devices, Aprevo® Transforaminal Lumbar Interbody Fusion Devices

Intervertebral Fusion Device With Bone Graft, Lumbar

Carlsmed, Inc.

The following data is part of a premarket notification filed by Carlsmed, Inc. with the FDA for Aprevo® Anterior And Lateral Lumbar Interbody Fusion Devices, Aprevo® Transforaminal Lumbar Interbody Fusion Devices.

Pre-market Notification Details

• Device ID: K222082
• 510k Number: K222082
• Device Name: Aprevo® Anterior And Lateral Lumbar Interbody Fusion Devices, Aprevo® Transforaminal Lumbar Interbody Fusion Devices
• Classification: Intervertebral Fusion Device With Bone Graft, Lumbar
• Applicant: Carlsmed, Inc. 1800 Aston Ave., Ste 100 Carlsbad, CA 92008
• Contact: Karen Liu
• Correspondent: Karen Liu; Carlsmed, Inc. 1800 Aston Ave., Ste 100 Carlsbad, CA 92008
• Product Code: MAX
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2022-07-15
• Decision Date: 2022-08-12