| Primary Device ID | 00840019957236 |
| NIH Device Record Key | 67a9a634-5c2f-411e-b336-b3968f9309bf |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Reform Ti HA Coated Pedicle Screw |
| Version Model Number | 39-HTC-8550 |
| Catalog Number | 39-HTC-8550 |
| 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 | true |
| 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 | 00840019957236 [Primary] |
| NKB | Thoracolumbosacral Pedicle Screw System |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-07-29 |
| Device Publish Date | 2022-07-21 |
| 00815362029817 | 10.5 x 120mm Reform Ti HA Coated Pedicle Screw |
| 00815362029800 | 10.5 x 110mm Reform Ti HA Coated Pedicle Screw |
| 00815362029794 | 10.5 x 100mm Reform Ti HA Coated Pedicle Screw |
| 00815362029787 | 10.5 x 90mm Reform Ti HA Coated Pedicle Screw |
| 00815362029770 | 10.5 x 80mm Reform Ti HA Coated Pedicle Screw |
| 00815362029763 | 10.5 x 70mm Reform Ti HA Coated Pedicle Screw |
| 00815362029756 | 10.5 x 60mm Reform Ti HA Coated Pedicle Screw |
| 00815362029749 | 10.5 x 55mm Reform Ti HA Coated Pedicle Screw |
| 00815362029732 | 10.5 x 50mm Reform Ti HA Coated Pedicle Screw |
| 00815362029725 | 10.5 x 45mm Reform Ti HA Coated Pedicle Screw |
| 00815362029718 | 10.5 x 40mm Reform Ti HA Coated Pedicle Screw |
| 00815362029497 | 9.5 x 120mm Reform Ti HA Coated Pedicle Screw |
| 00815362029480 | 9.5 x 110mm Reform Ti HA Coated Pedicle Screw |
| 00815362029473 | 9.5 x 100mm Reform Ti HA Coated Pedicle Screw |
| 00815362029466 | 9.5 x 90mm Reform Ti HA Coated Pedicle Screw |
| 00815362029459 | 9.5 x 80mm Reform Ti HA Coated Pedicle Screw |
| 00815362029442 | 9.5 x 70mm Reform Ti HA Coated Pedicle Screw |
| 00815362029435 | 9.5 x 60mm Reform Ti HA Coated Pedicle Screw |
| 00815362029428 | 9.5 x 55mm Reform Ti HA Coated Pedicle Screw |
| 00815362029411 | 9.5 x 50mm Reform Ti HA Coated Pedicle Screw |
| 00815362029404 | 9.5 x 45mm Reform Ti HA Coated Pedicle Screw |
| 00815362029398 | 9.5 x 40mm Reform Ti HA Coated Pedicle Screw |
| 00815362029381 | 8.5 x 120mm Reform Ti HA Coated Pedicle Screw |
| 00815362029374 | 8.5 x 110mm Reform Ti HA Coated Pedicle Screw |
| 00815362029367 | 8.5 x 100mm Reform Ti HA Coated Pedicle Screw |
| 00815362029350 | 8.5 x 90mm Reform Ti HA Coated Pedicle Screw |
| 00815362029343 | 8.5 x 80mm Reform Ti HA Coated Pedicle Screw |
| 00815362029336 | 8.5 x 70mm Reform Ti HA Coated Pedicle Screw |
| 00815362029329 | 8.5 x 60mm Reform Ti HA Coated Pedicle Screw |
| 00815362029312 | 8.5 x 55mm Reform Ti HA Coated Pedicle Screw |
| 00815362029305 | 8.5 x 50mm Reform Ti HA Coated Pedicle Screw |
| 00815362029299 | 8.5 x 45mm Reform Ti HA Coated Pedicle Screw |
| 00815362029282 | 8.5 x 40mm Reform Ti HA Coated Pedicle Screw |
| 00815362029275 | 8.5 x 35mm Reform Ti HA Coated Pedicle Screw |
| 00815362029268 | 7.5 x 80mm Reform Ti HA Coated Pedicle Screw |
| 00815362029251 | 7.5 x 75mm Reform Ti HA Coated Pedicle Screw |
| 00815362029244 | 7.5 x 60mm Reform Ti HA Coated Pedicle Screw |
| 00815362029237 | 7.5 x 55mm Reform Ti HA Coated Pedicle Screw |
| 00815362029220 | 7.5 x 50mm Reform Ti HA Coated Pedicle Screw |
| 00815362029213 | 7.5 x 45mm Reform Ti HA Coated Pedicle Screw |
| 00815362029206 | 7.5 x 40mm Reform Ti HA Coated Pedicle Screw |
| 00815362029190 | 7.5 x 35mm Reform Ti HA Coated Pedicle Screw |
| 00815362029183 | 7.5 x 30mm Reform Ti HA Coated Pedicle Screw |
| 00815362029176 | 6.5 x 60mm Reform Ti HA Coated Pedicle Screw |
| 00815362029169 | 6.5 x 55mm Reform Ti HA Coated Pedicle Screw |
| 00815362029152 | 6.5 x 50mm Reform Ti HA Coated Pedicle Screw |
| 00815362029145 | 6.5 x 45mm Reform Ti HA Coated Pedicle Screw |
| 00815362029138 | 6.5 x 40mm Reform Ti HA Coated Pedicle Screw |
| 00815362029121 | 6.5 x 35mm Reform Ti HA Coated Pedicle Screw |
| 00815362029114 | 6.5 x 30mm Reform Ti HA Coated Pedicle Screw |