OpenLoc-L Spinal Fixation System

Thoracolumbosacral Pedicle Screw System

L&K Biomed Co., Ltd.

The following data is part of a premarket notification filed by L&k Biomed Co., Ltd. with the FDA for Openloc-l Spinal Fixation System.

Pre-market Notification Details

• Device ID: K183168
• 510k Number: K183168
• Device Name: OpenLoc-L Spinal Fixation System
• Classification: Thoracolumbosacral Pedicle Screw System
• Applicant: L&K Biomed Co., Ltd. #201, 202 16-25, Dongbaekjungang-ro 16 Beon-gil, Giheung-gu Yongin-si, KR 17015
• Contact: Jihyeon Seo
• Correspondent: Jihyeon Seo; L&K Biomed Co., Ltd. #201, 202 16-25, Dongbaekjungang-ro 16 Beon-gil, Giheung-gu Yongin-si, KR 17015
• Product Code: NKB
• Subsequent Product Code: KWP
• Subsequent Product Code: KWQ
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-11-16
• Decision Date: 2018-12-11
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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