Pro-Link® Ti 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® Ti Stand-alone Cervical Spacer System.

Pre-market Notification Details

• Device ID: K180642
• 510k Number: K180642
• Device Name: Pro-Link® Ti 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: 2018-03-12
• Decision Date: 2018-05-10
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00190837031541	K180642	000
00190837031534	K180642	000
00190837031527	K180642	000
00190837031510	K180642	000
00190837031503	K180642	000
00190837031497	K180642	000
00190837031480	K180642	000
00190837031473	K180642	000