| Primary Device ID | 00817771027637 |
| NIH Device Record Key | a987559b-d5f4-4989-95ce-c5f22e523f30 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SpineSmith IN:C2 Spinal Fixation System |
| Version Model Number | 1100-0002-PL |
| Catalog Number | 1100-0002-PL |
| Company DUNS | 021560394 |
| Company Name | Celling Biosciences |
| 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 | true |
| 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 | 00817771027637 [Primary] |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00817771027637]
Moist Heat or Steam Sterilization
[00817771027637]
Moist Heat or Steam Sterilization
[00817771027637]
Moist Heat or Steam Sterilization
[00817771027637]
Moist Heat or Steam Sterilization
[00817771027637]
Moist Heat or Steam Sterilization
[00817771027637]
Moist Heat or Steam Sterilization
[00817771027637]
Moist Heat or Steam Sterilization
[00817771027637]
Moist Heat or Steam Sterilization
[00817771027637]
Moist Heat or Steam Sterilization
[00817771027637]
Moist Heat or Steam Sterilization
[00817771027637]
Moist Heat or Steam Sterilization
[00817771027637]
Moist Heat or Steam Sterilization
[00817771027637]
Moist Heat or Steam Sterilization
[00817771027637]
Moist Heat or Steam Sterilization
[00817771027637]
Moist Heat or Steam Sterilization
[00817771027637]
Moist Heat or Steam Sterilization
[00817771027637]
Moist Heat or Steam Sterilization
[00817771027637]
Moist Heat or Steam Sterilization
[00817771027637]
Moist Heat or Steam Sterilization
[00817771027637]
Moist Heat or Steam Sterilization
[00817771027637]
Moist Heat or Steam Sterilization
[00817771027637]
Moist Heat or Steam Sterilization
[00817771027637]
Moist Heat or Steam Sterilization
[00817771027637]
Moist Heat or Steam Sterilization
[00817771027637]
Moist Heat or Steam Sterilization
[00817771027637]
Moist Heat or Steam Sterilization
[00817771027637]
Moist Heat or Steam Sterilization
[00817771027637]
Moist Heat or Steam Sterilization
[00817771027637]
Moist Heat or Steam Sterilization
[00817771027637]
Moist Heat or Steam Sterilization
[00817771027637]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2020-02-24 |
| Device Publish Date | 2018-02-14 |
| 00817771029822 | IN:C2 Cervical System Kit w/stopless Trials |
| 00817771029815 | IN:C2 Cervical System Kit w/Stopless Trials |
| 00817771027637 | IN:C2 Cervical System Kit |