| Primary Device ID | 04719873287796 |
| NIH Device Record Key | 95fab349-750c-4d00-b48d-8a5195402327 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Syntec OS Spinal Fixation System |
| Version Model Number | 853087 |
| Catalog Number | 853087 |
| Company DUNS | 657692971 |
| Company Name | SYNTEC SCIENTIFIC CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| 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 | false |
| Manufacturing Date | true |
| 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 | 04719873287796 [Primary] |
| KWP | Appliance, Fixation, Spinal Interlaminal |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04719873287796]
Moist Heat or Steam Sterilization
[04719873287796]
Moist Heat or Steam Sterilization
[04719873287796]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-02-13 |
| Device Publish Date | 2026-02-05 |
| 04719873287833 | Smooth Rodφ5.5 x L120mm |
| 04719873287796 | Smooth Rodφ5.5 x L100mm |
| 04719873286607 | Polyaxial Long Arm Pedicle Screwφ5.0 x L40mm |
| 04719873285167 | Set Screw H5.0mm |
| 04719873284986 | Polyaxial Pedicle Screwφ6.5 x L45mm |
| 04716873713751 | Cross-Link 50/70mm |