Dakota ALIF System

Intervertebral Fusion Device With Integrated Fixation, Lumbar

Precision Spine, Inc.

The following data is part of a premarket notification filed by Precision Spine, Inc. with the FDA for Dakota Alif System.

Pre-market Notification Details

• Device ID: K213118
• 510k Number: K213118
• Device Name: Dakota ALIF System
• Classification: Intervertebral Fusion Device With Integrated Fixation, Lumbar
• Applicant: Precision Spine, Inc. 2050 Executive Drive. Pear, MS 39208
• Contact: Michael Dawson
• Correspondent: Nathan Wright; 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: 2021-09-27
• Decision Date: 2022-04-01

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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