Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K192096
Omnia Medical Trauma Screws · Omnia Medical, LLC · decided 2020-02-27 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Omnia Medical Golden Spike | OM-TLS4019-T | OMNIA MEDICAL, LLC | HWC | 00843511128586 |
| Omnia Medical Golden Spike | OM-TLS4028 | OMNIA MEDICAL, LLC | HWC | 00843511100766 |
| Omnia Medical Golden Spike | OM-TLS4040-T | OMNIA MEDICAL, LLC | HWC | 00843511122966 |
| Golden Spike | OM-TLS4545-T | OMNIA MEDICAL, LLC | HWC | 00843511122881 |
| Omnia Medical Golden Spike | OM-TLS4031-T | OMNIA MEDICAL, LLC | HWC | 00843511128678 |
| Omnia Medical Golden Spike | OM-TLS4032 | OMNIA MEDICAL, LLC | HWC | 00843511100780 |
| Omnia Medical Golden Spike | OM-TLS4025-T | OMNIA MEDICAL, LLC | HWC | 00843511128647 |
| Omnia Medical Golden Spike | OM-TLS4027-T | OMNIA MEDICAL, LLC | HWC | 00843511128654 |
| Golden Spike | OM-TLS4540-T | OMNIA MEDICAL, LLC | HWC | 00843511122874 |
| Omnia Medical Golden Spike | OM-TLS4043-T | OMNIA MEDICAL, LLC | HWC | 00843511128739 |
| Omnia Medical Golden Spike | OM-TLS4046-T | OMNIA MEDICAL, LLC | HWC | 00843511122997 |
| Omnia Medical Golden Spike | OM-TLS4016-T | OMNIA MEDICAL, LLC | HWC | 00843511128555 |
| Omnia Medical Golden Spike | OM-TLS4042-T | OMNIA MEDICAL, LLC | HWC | 00843511122973 |
| Omnia Medical Golden Spike | OM-TLS4026-T | OMNIA MEDICAL, LLC | HWC | 00843511122898 |
| Omnia Medical Golden Spike | OM-TLS4036 | OMNIA MEDICAL, LLC | HWC | 00843511100803 |
| Omnia Medical Golden Spike | OM-TLS4018-T | OMNIA MEDICAL, LLC | HWC | 00843511128579 |
| Omnia Medical Golden Spike | OM-TLS4039-T | OMNIA MEDICAL, LLC | HWC | 00843511128715 |
| Golden Spike | OM-TLS4545 | OMNIA MEDICAL, LLC | HWC | 00843511100742 |
| Omnia Medical Golden Spike | OM-TLS4044 | OMNIA MEDICAL, LLC | HWC | 00843511100841 |
| Omnia Medical Golden Spike | OM-TLS4022-T | OMNIA MEDICAL, LLC | HWC | 00843511128616 |
| Omnia Medical Golden Spike | OM-TLS4026 | OMNIA MEDICAL, LLC | HWC | 00843511100759 |
| Omnia Medical Golden Spike | OM-TLS4030 | OMNIA MEDICAL, LLC | HWC | 00843511100773 |
| Omnia Medical Golden Spike | OM-TLS4041-T | OMNIA MEDICAL, LLC | HWC | 00843511128722 |
| Omnia Medical Golden Spike | OM-TLS4050-T | OMNIA MEDICAL, LLC | HWC | 00843511123017 |
| Omnia Medical Golden Spike | OM-TLS4024-T | OMNIA MEDICAL, LLC | HWC | 00843511128630 |