The following data is part of a premarket notification filed by Dio Medical Corporation with the FDA for Unity Sacroiliac Joint Fixation System.
| Device ID | K222448 |
| 510k Number | K222448 |
| Device Name: | UNITY Sacroiliac Joint Fixation System |
| Classification | Sacroiliac Joint Fixation |
| Applicant | Dio Medical Corporation 2100 Campus Lane Suite 100 East Norriton, PA 19403 |
| Contact | Milan George |
| Correspondent | Milan George Dio Medical Corporation 2100 Campus Lane Suite 100 East Norriton, PA 19403 |
| Product Code | OUR |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-08-15 |
| Decision Date | 2022-10-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850051372263 | K222448 | 000 |
| 00850051372119 | K222448 | 000 |
| 00850051372102 | K222448 | 000 |
| 00850051372096 | K222448 | 000 |
| 00850051372089 | K222448 | 000 |
| 00850051372072 | K222448 | 000 |
| 00850051372065 | K222448 | 000 |
| 00850051372058 | K222448 | 000 |
| 00850051372041 | K222448 | 000 |
| 00850051372034 | K222448 | 000 |
| 00850051372027 | K222448 | 000 |
| 00850051372010 | K222448 | 000 |
| 00850051372126 | K222448 | 000 |
| 00850051372133 | K222448 | 000 |
| 00850051372140 | K222448 | 000 |
| 00850051372256 | K222448 | 000 |
| 00850051372249 | K222448 | 000 |
| 00850051372232 | K222448 | 000 |
| 00850051372225 | K222448 | 000 |
| 00850051372218 | K222448 | 000 |
| 00850051372201 | K222448 | 000 |
| 00850051372195 | K222448 | 000 |
| 00850051372188 | K222448 | 000 |
| 00850051372171 | K222448 | 000 |
| 00850051372164 | K222448 | 000 |
| 00850051372157 | K222448 | 000 |
| 00850051372003 | K222448 | 000 |