The following data is part of a premarket notification filed by Kyungwon Medical Co., Ltd. with the FDA for Tyche Pedicle Screw System.
| Device ID | K100373 |
| 510k Number | K100373 |
| Device Name: | TYCHE PEDICLE SCREW SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | KYUNGWON MEDICAL CO., LTD. 13340 E FIRESTONE BLVD. SUITE J Santa Fe Springs, CA 90670 |
| Contact | Joyce Bang |
| Correspondent | Joyce Bang KYUNGWON MEDICAL CO., LTD. 13340 E FIRESTONE BLVD. SUITE J Santa Fe Springs, CA 90670 |
| Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-12 |
| Decision Date | 2010-06-30 |
| Summary: | summary |