APEX SPINE SYSTEM

Thoracolumbosacral Pedicle Screw System

SPINECRAFT LLC

The following data is part of a premarket notification filed by Spinecraft Llc with the FDA for Apex Spine System.

Pre-market Notification Details

• Device ID: K110906
• 510k Number: K110906
• Device Name: APEX SPINE SYSTEM
• Classification: Thoracolumbosacral Pedicle Screw System
• Applicant: SPINECRAFT LLC 2215 ENTERPRISE DRIVE SUITE 1504 Westchester, IL 60154
• Contact: Ami Akallal-asaad
• Correspondent: Ami Akallal-asaad; SPINECRAFT LLC 2215 ENTERPRISE DRIVE SUITE 1504 Westchester, IL 60154
• Product Code: NKB
• Subsequent Product Code: KWP
• Subsequent Product Code: KWQ
• 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: 2011-03-31
• Decision Date: 2011-07-26
• Summary: summary