XENON(TM) PEDICLE SCREW SYSTEM

Thoracolumbosacral Pedicle Screw System

ALPHATEC SPINE, INC.

The following data is part of a premarket notification filed by Alphatec Spine, Inc. with the FDA for Xenon(tm) Pedicle Screw System.

Pre-market Notification Details

• Device ID: K111634
• 510k Number: K111634
• Device Name: XENON(TM) PEDICLE SCREW SYSTEM
• Classification: Thoracolumbosacral Pedicle Screw System
• Applicant: ALPHATEC SPINE, INC. 5818 EL CAMINO REAL Carlsbad, CA 92008
• Contact: Cheryl Allen
• Correspondent: Cheryl Allen; ALPHATEC SPINE, INC. 5818 EL CAMINO REAL Carlsbad, CA 92008
• Product Code: NKB
• Subsequent Product Code: MNH
• Subsequent Product Code: MNI
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-06-13
• Decision Date: 2012-01-25
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00844856077416	K111634	000
00844856077621	K111634	000
00844856077638	K111634	000
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