| Primary Device ID | 00841732135239 |
| NIH Device Record Key | 9fa9c054-cc23-4b33-823f-f4e7ea3f152f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RODIN Expandable Lumbar Cage System |
| Version Model Number | 027.7222 |
| Catalog Number | 027.7222 |
| Company DUNS | 080138504 |
| Company Name | CTL Medical 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 | false |
| 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 |
| Phone | 214-545-5820 |
| schedule@ctlamedica.com | |
| Phone | 214-545-5820 |
| schedule@ctlamedica.com | |
| Phone | 214-545-5820 |
| schedule@ctlamedica.com | |
| Phone | 214-545-5820 |
| schedule@ctlamedica.com | |
| Phone | 214-545-5820 |
| schedule@ctlamedica.com | |
| Phone | 214-545-5820 |
| schedule@ctlamedica.com | |
| Phone | 214-545-5820 |
| schedule@ctlamedica.com | |
| Phone | 214-545-5820 |
| schedule@ctlamedica.com | |
| Phone | 214-545-5820 |
| schedule@ctlamedica.com | |
| Phone | 214-545-5820 |
| schedule@ctlamedica.com | |
| Phone | 214-545-5820 |
| schedule@ctlamedica.com | |
| Phone | 214-545-5820 |
| schedule@ctlamedica.com | |
| Phone | 214-545-5820 |
| schedule@ctlamedica.com | |
| Phone | 214-545-5820 |
| schedule@ctlamedica.com | |
| Phone | 214-545-5820 |
| schedule@ctlamedica.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841732135239 [Primary] |
| MQP | Spinal vertebral body replacement device |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00841732135239]
Moist Heat or Steam Sterilization
[00841732135239]
Moist Heat or Steam Sterilization
[00841732135239]
Moist Heat or Steam Sterilization
[00841732135239]
Moist Heat or Steam Sterilization
[00841732135239]
Moist Heat or Steam Sterilization
[00841732135239]
Moist Heat or Steam Sterilization
[00841732135239]
Moist Heat or Steam Sterilization
[00841732135239]
Moist Heat or Steam Sterilization
[00841732135239]
Moist Heat or Steam Sterilization
[00841732135239]
Moist Heat or Steam Sterilization
[00841732135239]
Moist Heat or Steam Sterilization
[00841732135239]
Moist Heat or Steam Sterilization
[00841732135239]
Moist Heat or Steam Sterilization
[00841732135239]
Moist Heat or Steam Sterilization
[00841732135239]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-05-16 |
| Device Publish Date | 2024-05-08 |
| 00841732165090 | Remover Collet, Lever |
| 00841732165083 | Remover Tamp, H8-H10, Lever |
| 00841732154049 | RODIN MIS Cage, 0°, W27xL21, H14mm |
| 00841732154032 | RODIN MIS Cage, 0°, W27xL21, H13mm |
| 00841732154025 | RODIN MIS Cage, 0°, W27xL21, H12mm |
| 00841732154018 | RODIN MIS Cage, 0°, W27xL21, H11mm |
| 00841732154001 | RODIN MIS Cage, 0°, W27xL21, H10mm |
| 00841732153998 | RODIN MIS Cage, 0°, W27xL21, H9mm |
| 00841732153981 | RODIN MIS Cage, 0°, W27xL21, H8mm |
| 00841732143067 | T - HANDLE , QC, SO, M 5, GRAY |
| 00841732143029 | ANTI DEPLOYMENT SLEEVE |
| 00841732141377 | RODIN Trial, 0°, W30xL25, H14mm |
| 00841732141360 | RODIN Trial, 0°, W30xL25, H13mm |
| 00841732141353 | RODIN Trial, 0°, W30xL25, H12mm |
| 00841732141346 | RODIN Trial, 0°, W30xL25, H11mm |
| 00841732141339 | RODIN Trial, 0°, W30xL25, H10mm |
| 00841732141322 | RODIN Trial, 0°, W30xL25, H9mm |
| 00841732141315 | RODIN Trial, 0°, W30xL25, H8mm |
| 00841732141308 | RODIN Box Cutter, 15mm |
| 00841732141292 | RODIN Box Cutter, 14mm |
| 00841732141285 | RODIN Box Cutter, 13mm |
| 00841732141278 | RODIN Box Cutter, 12mm |
| 00841732141261 | RODIN Box Cutter, 11mm |
| 00841732141254 | RODIN MIS Cage, 6°, W27xL21, H14mm |
| 00841732141247 | RODIN MIS Cage, 6°, W27xL21, H13mm |
| 00841732141230 | RODIN MIS Cage, 6°, W27xL21, H12mm |
| 00841732141223 | RODIN MIS Cage, 6°, W27xL21, H11mm |
| 00841732141216 | RODIN MIS Cage, 6°, W27xL21, H10mm |
| 00841732141209 | RODIN MIS Cage, 6°, W27xL21, H9mm |
| 00841732141193 | RODIN MIS Cage, 6°, W27xL21, H8mm |
| 00841732141001 | Expansion Driver, 1/4" QC, Impactor Lever |
| 00841732140998 | Inserter Collet |
| 00841732140875 | Expansion Driver, 1/4" QC, Lever |
| 00841732140868 | Expansion Tamp |
| 00841732140844 | RODIN Implant Inserter, Lever |
| 00841732140813 | RODIN Disc Shaver, 14mm |
| 00841732140806 | RODIN Disc Shaver, 13mm |
| 00841732140790 | RODIN Disc Shaver, 12mm |
| 00841732140783 | RODIN Disc Shaver, 11mm |
| 00841732140776 | RODIN Disc Shaver, 10mm |
| 00841732140769 | RODIN Disc Shaver, 9mm |
| 00841732140752 | RODIN Disc Shaver, 8mm |
| 00841732140745 | RODIN Disc Shaver, 7mm |
| 00841732140738 | RODIN Trial, 6°, W30xL25,H14mm |
| 00841732140721 | RODIN Trial, 6°, W30xL25,H13mm |
| 00841732140714 | RODIN Trial, 6°, W30xL25,H12mm |
| 00841732140707 | RODIN Trial, 6°, W30xL25,H11mm |
| 00841732140691 | RODIN Trial, 6°, W30xL25,H10mm |
| 00841732140684 | RODIN Trial, 6°, W30xL25,H9mm |
| 00841732140677 | RODIN Trial, 6°, W30xL25,H8mm |