The following data is part of a premarket notification filed by Dio Medical Co., Ltd. with the FDA for Fixpine Ii System.
| Device ID | K100765 |
| 510k Number | K100765 |
| Device Name: | FIXPINE II SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | DIO MEDICAL CO., LTD. 13340 E. FIRESTONE BLVD. SUITE J Santa Fe Springs, CA 90670 |
| Contact | Joyce Bang |
| Correspondent | Joyce Bang DIO MEDICAL CO., LTD. 13340 E. FIRESTONE BLVD. SUITE J Santa Fe Springs, CA 90670 |
| Product Code | MNI |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-17 |
| Decision Date | 2010-07-19 |
| Summary: | summary |