| Primary Device ID | 00813892021011 |
| NIH Device Record Key | 57845d3d-aa38-4f93-8cde-52ce1c3d09f8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Outologous Spinal Fixation System |
| Version Model Number | TL1040 |
| Catalog Number | TL1040 |
| Company DUNS | 068109169 |
| Company Name | Orthopedic Sciences 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 | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | +1(562)799-5550 |
| info@orthopedicsciences.com | |
| Phone | +1(562)799-5550 |
| info@orthopedicsciences.com |
| Length | 40 Millimeter |
| Length | 40 Millimeter |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00813892021011 [Primary] |
| MNH | Orthosis, spondylolisthesis spinal fixation |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00813892021011]
Moist Heat or Steam Sterilization
[00813892021011]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-10-13 |
| 00813892021073 | Cross Link Nut |
| 00813892021066 | Cross Link Hook |
| 00813892021059 | 80mm Cross Link |
| 00813892021042 | 70mm Cross Link |
| 00813892021035 | 60mm Cross Link |
| 00813892021028 | 50mm Cross Link |
| 00813892021011 | 40mm Cross Link |
| 00813892021004 | Set Screw |
| 00813892020991 | 6.0 x 150mm Titanium Rod |
| 00813892020984 | 6. 0x 120mm Titanium Rod |
| 00813892020977 | 6.0 x 100mm Titanium Rod |
| 00813892020960 | 6.0 x 90mm Titanium Rod |
| 00813892020953 | 6.0 x 80mm Titanium Rod |
| 00813892020946 | 6.0 x 70mm Titanium Rod |
| 00813892020939 | 6.0 x 60mm Titanium Rod |
| 00813892020922 | 6.0 x 50mm Titanium Rod |
| 00813892020915 | 6.0 x 40mm Titanium Rod |
| 00813892020908 | 7.0 X 60mm Titanium Pedicle Screw Self Tapping |
| 00813892020892 | 7.0 X 55mm Titanium Pedicle Screw Self Tapping |
| 00813892020885 | 7.0 X 50mm Titanium Pedicle Screw Self Tapping |
| 00813892020878 | 7.0 X 45mm Titanium Pedicle Screw Self Tapping |
| 00813892020861 | 7.0 X 40mm Titanium Pedicle Screw Self Tapping |
| 00813892020854 | 7.0 X 35mm Titanium Pedicle Screw Self Tapping |
| 00813892020847 | 7.0 X 30mm Titanium Pedicle Screw Self Tapping |
| 00813892020830 | 6.0 X 60mm Titanium Pedicle Screw Self Tapping |
| 00813892020823 | 6.0 X 55mm Titanium Pedicle Screw Self Tapping |
| 00813892020816 | 6.0 X 50mm Titanium Pedicle Screw Self Tapping |
| 00813892020809 | 6.0 X 45mmTitanium Pedicle Screw Self Tapping |
| 00813892020793 | 6.0 X 40mm Titanium Pedicle Screw Self Tapping |
| 00813892020786 | 6.0 X 35mm Titanium Pedicle Screw Self Tapping |
| 00813892020779 | 6.0 X 30mm Titanium Pedicle Screw Self Tapping |