The following data is part of a premarket notification filed by Omnia Medical, Llc with the FDA for Omnia Medical Rotary Plif System.
| Device ID | K183659 |
| 510k Number | K183659 |
| Device Name: | Omnia Medical Rotary PLIF System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Omnia Medical, LLC 6 Canyon Rd Suite 300 Morgantown, WV 26508 |
| Contact | Troy Schifano |
| Correspondent | Daniel Johnson JALEX Medical 30311 Clemens Road Suite 5D Westlake, OH 44145 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-27 |
| Decision Date | 2019-02-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00843511100612 | K183659 | 000 |
| 00843511100537 | K183659 | 000 |
| 00843511100544 | K183659 | 000 |
| 00843511100551 | K183659 | 000 |
| 00843511100568 | K183659 | 000 |
| 00843511100575 | K183659 | 000 |
| 00843511100582 | K183659 | 000 |
| 00843511100599 | K183659 | 000 |
| 00843511100605 | K183659 | 000 |
| 00843511100520 | K183659 | 000 |