The following data is part of a premarket notification filed by L&k Biomed Co., Ltd with the FDA for Venus Basic Spinal Fixation System.
| Device ID | K103085 |
| 510k Number | K103085 |
| Device Name: | VENUS BASIC SPINAL FIXATION SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | L&K BIOMED CO., LTD #1104, ACE HIGH-END TOWER 2CHA, 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 2CHA, 371-50 GASAN-DONG Geumcheon-gu, Seoul, KR 153-803 |
| Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-19 |
| Decision Date | 2011-02-09 |
| Summary: | summary |