The following data is part of a premarket notification filed by L & K Biomed Co., Ltd with the FDA for Venus Lumbar Intervertebral Body Fusion Cage System.
| Device ID | K121096 |
| 510k Number | K121096 |
| Device Name: | VENUS LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | L & K BIOMED CO., LTD ROOM 1104, ACE HIGH-END TOWER3 371-50 GASAN-DONG, GEUMCHEON-G Seoul, KR 153803 |
| Contact | Ki Hyang Kim |
| Correspondent | Ki Hyang Kim L & K BIOMED CO., LTD ROOM 1104, ACE HIGH-END TOWER3 371-50 GASAN-DONG, GEUMCHEON-G Seoul, KR 153803 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-11 |
| Decision Date | 2012-07-06 |
| Summary: | summary |