InFill® Interbody Fusion Device

Intervertebral Fusion Device With Bone Graft, Lumbar

Pinnacle Spine Group, LLC

The following data is part of a premarket notification filed by Pinnacle Spine Group, Llc with the FDA for Infill® Interbody Fusion Device.

Pre-market Notification Details

• Device ID: K172349
• 510k Number: K172349
• Device Name: InFill® Interbody Fusion Device
• Classification: Intervertebral Fusion Device With Bone Graft, Lumbar
• Applicant: Pinnacle Spine Group, LLC 2921 Canton St. Dallas, TX 75226
• Contact: Zach Sowell
• Correspondent: Kenneth C. Maxwell; Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, CO 80918
• Product Code: MAX
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-08-03
• Decision Date: 2017-12-14
• Summary: summary