LnK Posterior Cervical Fixation System And CastleLoc-S Posterior Cervical Fixation System

Posterior Cervical 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 Lnk Posterior Cervical Fixation System And Castleloc-s Posterior Cervical Fixation System.

Pre-market Notification Details

• Device ID: K200793
• 510k Number: K200793
• Device Name: LnK Posterior Cervical Fixation System And CastleLoc-S Posterior Cervical Fixation System
• Classification: Posterior Cervical Screw System
• Applicant: L&K BIOMED Co., Ltd. #201, 202 16-25, Dongbaekjungang-ro 16 Beon-gil, Giheung-gu, Yongin-si, KR 17015
• Contact: Kihyang Kim
• Correspondent: Minju Choi; L&K BIOMED Co., Ltd. #201, 202 16-25, Dongbaekjungang-ro 16 Beon-gil, Giheung-gu, Yongin-si, KR 17015
• Product Code: NKG
• CFR Regulation Number: 888.3075 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-03-26
• Decision Date: 2020-10-08

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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