MEGA SPINE SYSTEM

Orthosis, Spinal Pedicle Fixation

BK MEDITECH CO., LTD.

The following data is part of a premarket notification filed by Bk Meditech Co., Ltd. with the FDA for Mega Spine System.

Pre-market Notification Details

• Device ID: K072436
• 510k Number: K072436
• Device Name: MEGA SPINE SYSTEM
• Classification: Orthosis, Spinal Pedicle Fixation
• Applicant: BK MEDITECH CO., LTD. 25041 FARRIER CIRCLE Laguna Hills, CA 92653
• Contact: Henry Yang
• Correspondent: Henry Yang; BK MEDITECH CO., LTD. 25041 FARRIER CIRCLE Laguna Hills, CA 92653
• Product Code: MNI
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-08-30
• Decision Date: 2007-11-01
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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