The following data is part of a premarket notification filed by Dio Medical Co., Ltd. with the FDA for Rexious Hook Fixation Systems.
| Device ID | K113324 |
| 510k Number | K113324 |
| Device Name: | REXIOUS HOOK FIXATION SYSTEMS |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | DIO MEDICAL CO., LTD. 325 N. PUENTE ST UNIT B Brea, CA 92821 |
| Contact | April Lee |
| Correspondent | April Lee DIO MEDICAL CO., LTD. 325 N. PUENTE ST UNIT B Brea, CA 92821 |
| Product Code | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-10 |
| Decision Date | 2012-03-28 |
| Summary: | summary |