XYcor® Expandable Spinal Spacer System

Intervertebral Fusion Device With Bone Graft, Lumbar

Alphatec Spine, Inc

The following data is part of a premarket notification filed by Alphatec Spine, Inc with the FDA for Xycor® Expandable Spinal Spacer System.

Pre-market Notification Details

• Device ID: K160646
• 510k Number: K160646
• Device Name: XYcor® Expandable Spinal Spacer System
• Classification: Intervertebral Fusion Device With Bone Graft, Lumbar
• Applicant: Alphatec Spine, Inc 5818 El Camino Real Carlsbad, CA 92008
• Contact: Renee Murphy
• Correspondent: Renee L. Murphy; Alphatec Spine, Inc 5818 El Camino Real Carlsbad, CA 92008
• Product Code: MAX
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-03-07
• Decision Date: 2016-08-24
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00841732131972	K160646	000
00841732131859	K160646	000
00841732131866	K160646	000
00841732131873	K160646	000
00841732131880	K160646	000
00841732131897	K160646	000
00841732131903	K160646	000
00841732131910	K160646	000
00841732131927	K160646	000
00841732131934	K160646	000
00841732131941	K160646	000
00841732131958	K160646	000
00841732131965	K160646	000
00841732131842	K160646	000