| Primary Device ID | 00815362020005 |
| NIH Device Record Key | 80840b68-a5e1-49e7-8b48-1f1f6648a07b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Reform HA Coated Pedicle Screw |
| Version Model Number | 39-PH-4525 |
| Catalog Number | 39-PH-4525 |
| 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 | true |
| Serial Number | true |
| 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 | 00815362020005 [Primary] |
| KWP | Appliance, Fixation, Spinal Interlaminal |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-08-07 |
| Device Publish Date | 2019-03-28 |
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| 00840019930932 - Reform POCT System | 2024-04-17 Ø3.5 x 34mm Polyaxial Screw - M/L Bias |
| 00840019930949 - Reform POCT System | 2024-04-17 Ø3.5 x 36mm Polyaxial Screw - M/L Bias |
| 00840019930956 - Reform POCT System | 2024-04-17 Ø3.5 x 38mm Polyaxial Screw - M/L Bias |
| 00840019930963 - Reform POCT System | 2024-04-17 Ø4.0 x 32mm Polyaxial Screw - M/L Bias |
| 00840019930970 - Reform POCT System | 2024-04-17 Ø4.0 x 34mm Polyaxial Screw - M/L Bias |
| 00840019930987 - Reform POCT System | 2024-04-17 Ø4.0 x 36mm Polyaxial Screw - M/L Bias |
| 00840019930994 - Reform POCT System | 2024-04-17 Ø4.0 x 38mm Polyaxial Screw - M/L Bias |