| Primary Device ID | 00840019902533 |
| NIH Device Record Key | bf5d7441-43ca-480b-9224-793227f86fa1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Reform TI Pedicle Screw System |
| Version Model Number | 39-TP-4545 |
| Catalog Number | 39-TP-4545 |
| 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 | true |
| 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 | 00840019902533 [Primary] |
| MNI | Orthosis, Spinal Pedicle Fixation |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840019902533]
Moist Heat or Steam Sterilization
[00840019902533]
Moist Heat or Steam Sterilization
[00840019902533]
Moist Heat or Steam Sterilization
[00840019902533]
Moist Heat or Steam Sterilization
[00840019902533]
Moist Heat or Steam Sterilization
[00840019902533]
Moist Heat or Steam Sterilization
[00840019902533]
Moist Heat or Steam Sterilization
[00840019902533]
Moist Heat or Steam Sterilization
[00840019902533]
Moist Heat or Steam Sterilization
[00840019902533]
Moist Heat or Steam Sterilization
[00840019902533]
Moist Heat or Steam Sterilization
[00840019902533]
Moist Heat or Steam Sterilization
[00840019902533]
Moist Heat or Steam Sterilization
[00840019902533]
Moist Heat or Steam Sterilization
[00840019902533]
Moist Heat or Steam Sterilization
[00840019902533]
Moist Heat or Steam Sterilization
[00840019902533]
Moist Heat or Steam Sterilization
[00840019902533]
Moist Heat or Steam Sterilization
[00840019902533]
Moist Heat or Steam Sterilization
[00840019902533]
Moist Heat or Steam Sterilization
[00840019902533]
Moist Heat or Steam Sterilization
[00840019902533]
Moist Heat or Steam Sterilization
[00840019902533]
Moist Heat or Steam Sterilization
[00840019902533]
Moist Heat or Steam Sterilization
[00840019902533]
Moist Heat or Steam Sterilization
[00840019902533]
Moist Heat or Steam Sterilization
[00840019902533]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-05-21 |
| Device Publish Date | 2019-05-13 |
| 00840019937252 | Instrument Kit 1 |
| 00840019937245 | Implant Kit: Std + Outlier Ply + Red (Cr) |
| 00840019937238 | Implant Kit: Std + Red (Cr) |
| 00840019937221 | Implant Kit: Std + Outlier Ply (Cr) |
| 00840019937214 | Implant Kit: Std: 5.5 - 7.5 Ply (Cr) |
| 00840019937207 | Implant Kit: Std + Outlier Ply + Red (Ti) |
| 00840019937184 | Implant Kit: Std + Outlier Ply (Ti) |
| 00840019937177 | Implant Kit: Std: 5.5 - 7.5 Ply (Ti) |
| 00840019935883 | Reduction Cannulated Polyaxial Screw Caddy |
| 00840019935876 | Outlier Cannulated Polyaxial Screw Caddy |
| 00840019935869 | ø7.5mm Cannulated Polyaxial Screw Caddy |
| 00840019935852 | ø6.5mm Cannulated Polyaxial Screw Caddy |
| 00840019935845 | ø5.5mm Cannulated Polyaxial Screw Caddy |
| 00840019935838 | Cannulated Instrument Kit 1 |
| 00840019935821 | Cannulated Implant Kit: Std + Outlier Ply + Red (Cr) |
| 00840019935814 | Cannulated Implant Kit: Std + Red (Cr) |
| 00840019935807 | Cannulated Implant Kit: Std + Outlier Ply (Cr) |
| 00840019935784 | Cannulated Implant Kit: Std + Outlier Ply + Red (Ti) |
| 00840019935777 | Cannulated Implant Kit: Std + Red (Ti) |
| 00840019935760 | Cannulated Implant Kit: Std + Outlier Ply (Ti) |
| 00840019935753 | Cannulated Implant Kit: Std: 5.5 - 7.5 Ply (Ti) |
| 00840019929226 | Reduction Polyaxial Screw Caddy |
| 00840019929219 | Outlier Polyaxial Screw Caddy |
| 00840019929202 | ø7.5mm Polyaxial Screw Caddy |
| 00840019929196 | ø6.5mm Polyaxial Screw Caddy |
| 00840019929189 | ø5.5mm Polyaxial Screw Caddy |
| 00840019929172 | Polyaxial Driver |
| 00840019929165 | Retention Bone-Screw Driver |
| 00840019903653 | 9.5 x 90mm Reduction Polyaxial Screw |
| 00840019903646 | 9.5 x 80mm Reduction Polyaxial Screw |
| 00840019903639 | 9.5 x 70mm Reduction Polyaxial Screw |
| 00840019903622 | 9.5 x 60mm Reduction Polyaxial Screw |
| 00840019903615 | 9.5 x 55mm Reduction Polyaxial Screw |
| 00840019903608 | 9.5 x 50mm Reduction Polyaxial Screw |
| 00840019903592 | 9.5 x 45mm Reduction Polyaxial Screw |
| 00840019903585 | 9.5 x 40mm Reduction Polyaxial Screw |
| 00840019903578 | 9.5 x 120mm Reduction Polyaxial Screw |
| 00840019903561 | 9.5 x 110mm Reduction Polyaxial Screw |
| 00840019903554 | 9.5 x 100mm Reduction Polyaxial Screw |
| 00840019903547 | 8.5 x 90mm Reduction Polyaxial Screw |
| 00840019903530 | 8.5 x 80mm Reduction Polyaxial Screw |
| 00840019903523 | 8.5 x 70mm Reduction Polyaxial Screw |
| 00840019903516 | 8.5 x 60mm Reduction Polyaxial Screw |
| 00840019903509 | 8.5 x 55mm Reduction Polyaxial Screw |
| 00840019903493 | 8.5 x 50mm Reduction Polyaxial Screw |
| 00840019903486 | 8.5 x 45mm Reduction Polyaxial Screw |
| 00840019903479 | 8.5 x 40mm Reduction Polyaxial Screw |
| 00840019903462 | 8.5 x 35mm Reduction Polyaxial Screw |
| 00840019903455 | 8.5 x 120mm Reduction Polyaxial Screw |
| 00840019903448 | 8.5 x 110mm Reduction Polyaxial Screw |