Adcura® Sagittae® Lateral Lumbar Interbody Fusion Devices

Intervertebral Fusion Device With Bone Graft, Lumbar

Adcura, Inc.

The following data is part of a premarket notification filed by Adcura, Inc. with the FDA for Adcura® Sagittae® Lateral Lumbar Interbody Fusion Devices.

Pre-market Notification Details

• Device ID: K223065
• 510k Number: K223065
• Device Name: Adcura® Sagittae® Lateral Lumbar Interbody Fusion Devices
• Classification: Intervertebral Fusion Device With Bone Graft, Lumbar
• Applicant: Adcura, Inc. 11010 Prairie Lakes Dr Ste 375 Eden Prairie, MN 55344
• Contact: Andrew Rogers
• Correspondent: Nathan Wright; Empirical Technologies 4628 Northpark Drive Colorado Springs, CO 80918
• Product Code: MAX
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2022-09-30
• Decision Date: 2022-10-26