SOLANAS POSTERIOR STABILIZATION SYSTEM

Appliance, Fixation, Spinal Interlaminal

ALPHATEC SPINE, INC.

The following data is part of a premarket notification filed by Alphatec Spine, Inc. with the FDA for Solanas Posterior Stabilization System.

Pre-market Notification Details

• Device ID: K052201
• 510k Number: K052201
• Device Name: SOLANAS POSTERIOR STABILIZATION SYSTEM
• Classification: Appliance, Fixation, Spinal Interlaminal
• Applicant: ALPHATEC SPINE, INC. 2051 PALOMAR AIRPORT ROAD SUITE 100 Carlsbad, CA 92011
• Contact: Ellen A Yarnall
• Correspondent: Ellen A Yarnall; ALPHATEC SPINE, INC. 2051 PALOMAR AIRPORT ROAD SUITE 100 Carlsbad, CA 92011
• Product Code: KWP
• CFR Regulation Number: 888.3050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-08-12
• Decision Date: 2005-11-10
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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