The following data is part of a premarket notification filed by L&k Biomed Co., Ltd with the FDA for Lexus Anterior Cervical Plate System.
Device ID | K113509 |
510k Number | K113509 |
Device Name: | LEXUS ANTERIOR CERVICAL PLATE SYSTEM |
Classification | Appliance, Fixation, Spinal Intervertebral Body |
Applicant | L&K BIOMED CO., LTD #1104, ACE HIGH-END TOWER 3 CHA, 371-50 GASAN-DONG Geumcheon-gu, Seoul, KR 153-803 |
Contact | Hee Kyeong Joo |
Correspondent | Hee Kyeong Joo L&K BIOMED CO., LTD #1104, ACE HIGH-END TOWER 3 CHA, 371-50 GASAN-DONG Geumcheon-gu, Seoul, KR 153-803 |
Product Code | KWQ |
CFR Regulation Number | 888.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-11-28 |
Decision Date | 2012-01-20 |
Summary: | summary |