| Primary Device ID | 00815362021071 |
| NIH Device Record Key | ef5ea3bf-2bf5-4d3d-8656-f1a74eba81e2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RCS Anterior Buttress Plate System |
| Version Model Number | 50-0001 |
| Catalog Number | 50-0001 |
| Company DUNS | 079398589 |
| Company Name | PRECISION SPINE, INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | false |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00815362021071 [Primary] |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00815362021071]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-08-28 |
| Device Publish Date | 2019-03-29 |
| 00815362021071 | Buttress Plate Case |
| 00815362021057 | RCS Buttress Screwdriver Straight 3.5mm |
| 00815362021040 | 22-9002 |
| 00815362021033 | RCS Buttress Inserter Tool |
| 00815362021026 | Self Drilling Screw 5.5mm x 35mm |
| 00815362021019 | Self Drilling Screw 5.5mm x 30mm |
| 00815362021002 | Self Drilling Screw 5.5mm x 25mm |
| 00815362020999 | Self Drilling Screw 5.5mm x 20mm |
| 00815362020982 | RCS Buttress Plate 30mm |
| 00815362020975 | RCS Buttress Plate 25mm |
| 00840019936224 | Buttress Plate Tray 1 Assembly |