| Primary Device ID | 00840019913676 |
| NIH Device Record Key | bc17b55f-010e-4b7c-bbf0-007f52ab8551 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PSS System |
| Version Model Number | SLP6550 |
| Catalog Number | SLP6550 |
| 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 | 00840019913676 [Primary] |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840019913676]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-05-10 |
| Device Publish Date | 2019-05-02 |
| 00840019931779 | Ø8.5 x 100mm Cannulated Reduction Pedicle Screw |
| 00840019931762 | Ø8.5 x 90mm Cannulated Reduction Pedicle Screw |
| 00840019931755 | Ø8.5 x 80mm Cannulated Reduction Pedicle Screw |
| 00840019931748 | Ø8.5 x 70mm Cannulated Reduction Pedicle Screw |
| 00840019931731 | Ø8.5 x 60mm Cannulated Reduction Pedicle Screw |
| 00840019931724 | Ø8.5 x 55mm Cannulated Reduction Pedicle Screw |
| 00840019931700 | Ø8.5 x 45mm Cannulated Reduction Pedicle Screw |
| 00840019931694 | Ø8.5 x 40mm Cannulated Reduction Pedicle Screw |
| 00840019931687 | Ø8.5 x 35mm Cannulated Reduction Pedicle Screw |
| 00840019931670 | Ø8.5 x 30mm Cannulated Reduction Pedicle Screw |
| 00840019931663 | Ø8.5 x 25mm Cannulated Reduction Pedicle Screw |
| 00840019931656 | Ø7.5 x 60mm Cannulated Reduction Pedicle Screw |
| 00840019931649 | Ø7.5 x 55mm Cannulated Reduction Pedicle Screw |
| 00840019931632 | Ø7.5 x 50mm Cannulated Reduction Pedicle Screw |
| 00840019931625 | Ø7.5 x 45mm Cannulated Reduction Pedicle Screw |
| 00840019931618 | Ø7.5 x 40mm Cannulated Reduction Pedicle Screw |
| 00840019931595 | Ø7.5 x 30mm Cannulated Reduction Pedicle Screw |
| 00840019931571 | Ø6.5 x 60mm Cannulated Reduction Pedicle Screw |
| 00840019931564 | Ø6.5 x 55mm Cannulated Reduction Pedicle Screw |
| 00840019931557 | Ø6.5 x 50mm Cannulated Reduction Pedicle Screw |
| 00840019931533 | Ø6.5 x 40mm Cannulated Reduction Pedicle Screw |
| 00840019931519 | Ø6.5 x 30mm Cannulated Reduction Pedicle Screw |
| 00840019931502 | Ø6.5 x 25mm Cannulated Reduction Pedicle Screw |
| 00840019931496 | Ø5.5 x 60mm Cannulated Reduction Pedicle Screw |
| 00840019931489 | Ø5.5 x 55mm Cannulated Reduction Pedicle Screw |
| 00840019931472 | Ø5.5 x 50mm Cannulated Reduction Pedicle Screw |
| 00840019931465 | Ø5.5 x 45mm Cannulated Reduction Pedicle Screw |
| 00840019931458 | Ø5.5 x 40mm Cannulated Reduction Pedicle Screw |
| 00840019931434 | Ø5.5 x 30mm Cannulated Reduction Pedicle Screw |
| 00840019931410 | Ø8.5 x 100mm Cannulated Pedicle Screw |
| 00840019931403 | Ø8.5 x 90mm Cannulated Pedicle Screw |
| 00840019931397 | Ø8.5 x 80mm Cannulated Pedicle Screw |
| 00840019931380 | Ø8.5 x 70mm Cannulated Pedicle Screw |
| 00840019931366 | Ø8.5 x 55mm Cannulated Pedicle Screw |
| 00840019931359 | Ø8.5 x 50mm Cannulated Pedicle Screw |
| 00840019931342 | Ø8.5 x 45mm Cannulated Pedicle Screw |
| 00840019931335 | Ø8.5 x 40mm Cannulated Pedicle Screw |
| 00840019931328 | Ø8.5 x 35mm Cannulated Pedicle Screw |
| 00840019931311 | Ø8.5 x 30mm Cannulated Pedicle Screw |
| 00840019931304 | Ø8.5 x 25mm Cannulated Pedicle Screw |
| 00840019931298 | Ø7.5 x 60mm Cannulated Pedicle Screw |
| 00840019931243 | Ø7.5 x 35mm Cannulated Pedicle Screw |
| 00840019931236 | Ø7.5 x 30mm Cannulated Pedicle Screw |
| 00840019931229 | Ø7.5 x 25mm Cannulated Pedicle Screw |
| 00840019931212 | Ø6.5 x 60mm Cannulated Pedicle Screw |
| 00840019931199 | Ø6.5 x 50mm Cannulated Pedicle Screw |
| 00840019931168 | Ø6.5 x 35mm Cannulated Pedicle Screw |
| 00840019931151 | Ø6.5 x 30mm Cannulated Pedicle Screw |
| 00840019931144 | Ø6.5 x 25mm Cannulated Pedicle Screw |
| 00840019931113 | Ø5.5 x 50mm Cannulated Pedicle Screw |