| Primary Device ID | M7391810506150 |
| NIH Device Record Key | 4997cb0a-426e-42cb-a477-07698cafb6dd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TirboLOX-C Cervical IBFD |
| Version Model Number | 18105-0615 |
| Company DUNS | 836975784 |
| Company Name | CAPTIVA 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 | false |
| Manufacturing Date | false |
| 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 | 877-772-5571 |
| info@captivaspine.com | |
| Phone | 877-772-5571 |
| info@captivaspine.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M7391810506150 [Primary] |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-05-12 |
| Device Publish Date | 2019-05-22 |
| M7391810714080 | 3D Cage - Lordotic (W)17.5 x (L)14 x (H)8mm |
| M7391810714070 | 3D Cage - Lordotic (W)17.5 x (L)14 x (H)7mm |
| M7391810714060 | 3D Cage - Lordotic (W)17.5 x (L)14 x (H)6mm |
| M7391810714050 | 3D Cage - Lordotic (W)17.5 x (L)14 x (H)5mm |
| M7391810712150 | 3D Cage - Lordotic (W)15 x (L)12 x (H)12mm |
| M7391810711150 | 3D Cage - Lordotic (W)15 x (L)12 x (H)11mm |
| M7391810710150 | 3D Cage - Lordotic (W)15 x (L)12 x (H)10mm |
| M7391810709150 | 3D Cage - Lordotic (W)15 x (L)12 x (H)9mm |
| M7391810708150 | 3D Cage - Lordotic (W)15 x (L)12 x (H)8mm |
| M7391810707150 | 3D Cage - Lordotic (W)15 x (L)12 x (H)7mm |
| M7391810706150 | 3D Cage - Lordotic (W)15 x (L)12 x (H)6mm |
| M7391810705150 | 3D Cage - Lordotic (W)15 x (L)12 x (H)5mm |
| M7391810510150 | 3D Cage - Anatomical (W)15 x (L)12 x (H)10mm |
| M7391810509150 | 3D Cage - Anatomical (W)15 x (L)12 x (H)9mm |
| M7391810508150 | 3D Cage - Anatomical (W)15 x (L)12 x (H)8mm |
| M7391810507150 | 3D Cage - Anatomical (W)15 x (L)12 x (H)7mm |
| M7391810506150 | 3D Cage - Anatomical (W)15 x (L)12 x (H)6mm |
| M7391810505150 | 3D Cage - Anatomical (W)15 x (L)12 x (H)5mm |
| M7391817512160 | Lordotic 7° Cage 16.5mm x 14mm x 12mm |
| M7391817511160 | Lordotic 7° Cage 16.5mm x 14mm x 11mm |
| M7391817510160 | Lordotic 7° Cage 16.5mm x 14mm x 10mm |
| M7391817509160 | Lordotic 7° Cage 16.5mm x 14mm x 9mm |
| M7391817508160 | Lordotic 7° Cage 16.5mm x 14mm x 8mm |
| M7391817507160 | Lordotic 7° Cage 16.5mm x 14mm x 7mm |
| M7391817506160 | Lordotic 7° Cage 16.5mm x 14mm x 6mm |
| M7391817505160 | Lordotic 7° Cage 16.5mm x 14mm x 5mm |
| M7391817012170 | Lordotic 7° Cage 17mm x 14mm x 12mm |
| M7391817012160 | Lordotic 7° Cage 16mm x 14mm x 12mm |
| M7391817011170 | Lordotic 7° Cage 17mm x 14mm x 11mm |
| M7391817011160 | Lordotic 7° Cage 16mm x 14mm x 11mm |
| M7391817010170 | Lordotic 7° Cage 17mm x 14mm x 10mm |
| M7391817010160 | Lordotic 7° Cage 16mm x 14mm x 10mm |
| M7391817009170 | Lordotic 7° Cage 17mm x 14mm x 9mm |
| M7391817009160 | Lordotic 7° Cage 16mm x 14mm x 9mm |
| M7391817008170 | Lordotic 7° Cage 17mm x 14mm x 8mm |
| M7391817008160 | Lordotic 7° Cage 16mm x 14mm x 8mm |
| M7391817007170 | Lordotic 7° Cage 17mm x 14mm x 7mm |
| M7391817007160 | Lordotic 7° Cage 16mm x 14mm x 7mm |
| M7391817006170 | Lordotic 7° Cage 17mm x 14mm x 6mm |
| M7391817006160 | Lordotic 7° Cage 16mm x 14mm x 6mm |
| M7391817005170 | Lordotic 7° Cage 17mm x 14mm x 5mm |
| M7391817005160 | Lordotic 7° Cage 16mm x 14mm x 5mm |
| M7391815712150 | Lordotic 7° Cage 15.5mm x 12mm x 12mm |
| M7391815712140 | Lordotic 7° Cage 14.5mm x 12mm x 12mm |
| M7391815711150 | Lordotic 7° Cage 15.5mm x 12mm x 11mm |
| M7391815711140 | Lordotic 7° Cage 14.5mm x 12mm x 11mm |
| M7391815710150 | Lordotic 7° Cage 15.5mm x 12mm x 10mm |
| M7391815710140 | Lordotic 7° Cage 14.5mm x 12mm x 10mm |
| M7391815709150 | Lordotic 7° Cage 15.5mm x 12mm x 9mm |
| M7391815709140 | Lordotic 7° Cage 14.5mm x 12mm x 9mm |