The following data is part of a premarket notification filed by Tae Yeon Medical Co., Ltd with the FDA for 4s Spinal System.
| Device ID | K063708 |
| 510k Number | K063708 |
| Device Name: | 4S SPINAL SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | TAE YEON MEDICAL CO., LTD 204, NAMDONG INDUSTRIAL COMPLEX, 45B-6L,# 435-6, N Incheon, KR 405-848 |
| Contact | Gil Woon Choi |
| Correspondent | Gil Woon Choi TAE YEON MEDICAL CO., LTD 204, NAMDONG INDUSTRIAL COMPLEX, 45B-6L,# 435-6, N Incheon, KR 405-848 |
| Product Code | MNI |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-13 |
| Decision Date | 2007-04-24 |
| Summary: | summary |