| Primary Device ID | M94310001701609 |
| NIH Device Record Key | 79d4fbd6-efb1-438b-adb2-353af8be7ccd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HA Minuteman G3 |
| Version Model Number | 10-0017-016 |
| Company DUNS | 963359513 |
| Company Name | SPINAL SIMPLICITY, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 913-451-4414 |
| information@spinalsimplicity.c | |
| Phone | 913-451-4414 |
| information@spinalsimplicity.com | |
| Phone | 913-451-4414 |
| information@spinalsimplicity.com | |
| Phone | 913-451-4414 |
| information@spinalsimplicity.com | |
| Phone | 913-451-4414 |
| information@spinalsimplicity.com | |
| Phone | 913-451-4414 |
| information@spinalsimplicity.com | |
| Phone | 913-451-4414 |
| information@spinalsimplicity.com | |
| Phone | 913-451-4414 |
| information@spinalsimplicity.com | |
| Phone | 913-451-4414 |
| information@spinalsimplicity.com | |
| Phone | 913-451-4414 |
| information@spinalsimplicity.com | |
| Phone | 913-451-4414 |
| information@spinalsimplicity.com | |
| Phone | 913-451-4414 |
| information@spinalsimplicity.com | |
| Phone | 913-451-4414 |
| information@spinalsimplicity.com | |
| Phone | 913-451-4414 |
| information@spinalsimplicity.com | |
| Phone | 913-451-4414 |
| information@spinalsimplicity.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M94310001701609 [Primary] |
| PEK | Spinous Process Plate |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-04-23 |
| Device Publish Date | 2016-03-30 |
| M94310001701609 | MIS Fusion Plate with HA coating |
| M94310001701407 | MIS Fusion Plate with HA coating |
| M94310001701205 | 10-0017-012 |
| M94310001701003 | 10-0017-010 |
| M9431000170080A | MIS Fusion Plate with HA coating |
| M9431000170140 | MIS Fusion Plate with HA coating |
| M9431000170120 | MIS Fusion Plate with HA coating |
| M9431000170100 | MIS Fusion Plate with HA coating |
| M9431000170080 | MIS Fusion Plate with HA coating |