The following data is part of a premarket notification filed by L&k Biomed Co., Ltd with the FDA for Focus Spinal System.
| Device ID | K120140 |
| 510k Number | K120140 |
| Device Name: | FOCUS SPINAL SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| 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 | NKB |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-18 |
| Decision Date | 2012-02-15 |
| Summary: | summary |