MEGA 5.5 SPINE SYSTEM

Orthosis, Spondylolisthesis Spinal Fixation

LSK BIOPARTNERS, INC.

The following data is part of a premarket notification filed by Lsk Biopartners, Inc. with the FDA for Mega 5.5 Spine System.

Pre-market Notification Details

• Device ID: K123476
• 510k Number: K123476
• Device Name: MEGA 5.5 SPINE SYSTEM
• Classification: Orthosis, Spondylolisthesis Spinal Fixation
• Applicant: LSK BIOPARTNERS, INC. 8 EAST BROADWAY, STE 611 Salt Lake City, UT 84111
• Contact: Shin Kuk Yoo
• Correspondent: Shin Kuk Yoo; LSK BIOPARTNERS, INC. 8 EAST BROADWAY, STE 611 Salt Lake City, UT 84111
• Product Code: MNH
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-11-13
• Decision Date: 2013-01-08
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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