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 |