LEUCADIA PEDICLE SCREW SYSTEM

Thoracolumbosacral Pedicle Screw System

PHYGEN, LLC

The following data is part of a premarket notification filed by Phygen, Llc with the FDA for Leucadia Pedicle Screw System.

Pre-market Notification Details

• Device ID: K110588
• 510k Number: K110588
• Device Name: LEUCADIA PEDICLE SCREW SYSTEM
• Classification: Thoracolumbosacral Pedicle Screw System
• Applicant: PHYGEN, LLC 2301 DUPONT DRIVE SUITE 510 Irvine, CA 92612
• Contact: Hartmut Loch
• Correspondent: Hartmut Loch; PHYGEN, LLC 2301 DUPONT DRIVE SUITE 510 Irvine, CA 92612
• 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: 2011-03-02
• Decision Date: 2011-05-25

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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