The following data is part of a premarket notification filed by L & K Biomed Co., Ltd with the FDA for Focus Mis System.
| Device ID | K112643 |
| 510k Number | K112643 |
| Device Name: | FOCUS MIS SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | L & K BIOMED CO., LTD ROOM 1104, ACE HIGH-END TOWER3 371-50 GASAN-DONG, GEUMCHEON-G Seoul, KR 153803 |
| Contact | Hee K Joo |
| Correspondent | Hee K Joo L & K BIOMED CO., LTD ROOM 1104, ACE HIGH-END TOWER3 371-50 GASAN-DONG, GEUMCHEON-G Seoul, KR 153803 |
| Product Code | NKB |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-12 |
| Decision Date | 2012-01-04 |
| Summary: | summary |