The following data is part of a premarket notification filed by Dio Medical Co., Ltd. with the FDA for Intervertebral Body Fusion Device.
| Device ID | K122872 |
| 510k Number | K122872 |
| Device Name: | INTERVERTEBRAL BODY FUSION DEVICE |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| 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 | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-19 |
| Decision Date | 2013-02-28 |
| Summary: | summary |