Pro-Link® Stand-Alone Cervical Spacer System

Intervertebral Fusion Device With Integrated Fixation, Cervical

Life Spine, Inc.

The following data is part of a premarket notification filed by Life Spine, Inc. with the FDA for Pro-link® Stand-alone Cervical Spacer System.

Pre-market Notification Details

• Device ID: K160066
• 510k Number: K160066
• Device Name: Pro-Link® Stand-Alone Cervical Spacer System
• Classification: Intervertebral Fusion Device With Integrated Fixation, Cervical
• Applicant: Life Spine, Inc. 13951 S. Quality Drive Huntley, IL 60142
• Contact: Randy Lewis
• Correspondent: Randy Lewis; Life Spine, Inc. 13951 S. Quality Drive Huntley, IL 60142
• Product Code: OVE
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-01-13
• Decision Date: 2016-09-02
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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