Align

Intervertebral Fusion Device With Integrated Fixation, Lumbar

Acuity Surgical Devices, LLC

The following data is part of a premarket notification filed by Acuity Surgical Devices, Llc with the FDA for Align.

Pre-market Notification Details

• Device ID: K222561
• 510k Number: K222561
• Device Name: Align
• Classification: Intervertebral Fusion Device With Integrated Fixation, Lumbar
• Applicant: Acuity Surgical Devices, LLC 8710 N Royal Lane Irving, TX 75063
• Contact: Bryan Cowan
• Correspondent: Lucie Dalet; RQM+ 2251 San Diego Ave, B-257 San Diego, CA 92110
• Product Code: OVD
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2022-08-24
• Decision Date: 2022-09-23