The following data is part of a premarket notification filed by L&k Biomed Co.,ltd. with the FDA for Venus Cervical Spinal Fixation System.
Device ID | K103414 |
510k Number | K103414 |
Device Name: | VENUS CERVICAL SPINAL FIXATION SYSTEM |
Classification | Orthosis, Spinal Pedicle Fixation |
Applicant | L&K BIOMED CO.,LTD. #1104 ACE HIGH-END TOWER 3 CHA 371-50 GASAN-DONG GEUMCHOEN-GU Seoul, KR 153-803 |
Contact | Sun Yi Lee |
Correspondent | Sun Yi Lee L&K BIOMED CO.,LTD. #1104 ACE HIGH-END TOWER 3 CHA 371-50 GASAN-DONG GEUMCHOEN-GU Seoul, KR 153-803 |
Product Code | MNI |
CFR Regulation Number | 888.3070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-11-22 |
Decision Date | 2011-07-22 |
Summary: | summary |