DVX SPINE SYSTEM

Orthosis, Spondylolisthesis Spinal Fixation

BK MEDITECH CO., LTD.

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

Pre-market Notification Details

• Device ID: K090424
• 510k Number: K090424
• Device Name: DVX SPINE SYSTEM
• Classification: Orthosis, Spondylolisthesis Spinal Fixation
• Applicant: BK MEDITECH CO., LTD. PO BOX 560 Stillwater, MN 55082
• Contact: Elaine Duncan
• Correspondent: Elaine Duncan; BK MEDITECH CO., LTD. PO BOX 560 Stillwater, MN 55082
• Product Code: MNH
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-02-19
• Decision Date: 2009-05-14
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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