| Primary Device ID | M7391910632090 |
| NIH Device Record Key | 6b5c1787-dd0f-4c26-bcbc-a6c43169774f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TirboLOX-L Lumbar IBFD |
| Version Model Number | 19106-3209 |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 561-277-9480 |
| info@captivaspine.com | |
| Phone | 561-277-9480 |
| info@captivaspine.com | |
| Phone | 561-277-9480 |
| info@captivaspine.com | |
| Phone | 561-277-9480 |
| info@captivaspine.com | |
| Phone | 561-277-9480 |
| info@captivaspine.com | |
| Phone | 561-277-9480 |
| info@captivaspine.com | |
| Phone | 561-277-9480 |
| info@captivaspine.com | |
| Phone | 561-277-9480 |
| info@captivaspine.com | |
| Phone | 561-277-9480 |
| info@captivaspine.com | |
| Phone | 561-277-9480 |
| info@captivaspine.com | |
| Phone | 561-277-9480 |
| info@captivaspine.com | |
| Phone | 561-277-9480 |
| info@captivaspine.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M7391910632090 [Primary] |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[M7391910632090]
Radiation Sterilization
[M7391910632090]
Radiation Sterilization
[M7391910632090]
Radiation Sterilization
[M7391910632090]
Radiation Sterilization
[M7391910632090]
Radiation Sterilization
[M7391910632090]
Radiation Sterilization
[M7391910632090]
Radiation Sterilization
[M7391910632090]
Radiation Sterilization
[M7391910632090]
Radiation Sterilization
[M7391910632090]
Radiation Sterilization
[M7391910632090]
Radiation Sterilization
[M7391910632090]
Radiation Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-10-09 |
| Device Publish Date | 2020-10-01 |
| M7391910925140 | Titanium convex lumbar cage 9.5mm W x 25mm L x 14mm H |
| M7391910925130 | Titanium convex lumbar cage 9.5mm W x 25mm L x 13mm H |
| M7391910925120 | Titanium convex lumbar cage 9.5mm W x 25mm L x 12mm H |
| M7391910925110 | Titanium convex lumbar cage 9.5mm W x 25mm L x 11mm H |
| M7391910925100 | Titanium convex lumbar cage 9.5mm W x 25mm L x 10mm H |
| M7391910925090 | Titanium convex lumbar cage 9.5mm W x 25mm L x 9mm H |
| M7391910925080 | Titanium convex lumbar cage 9.5mm W x 25mm L x 8mm H |
| M7391910925070 | Titanium convex lumbar cage 9.5mm W x 25mm L x 7mm H |
| M7391910922140 | Titanium lordotic lumbar cage 9.5mm W x 22mm L x 14mm H |
| M7391910922130 | Titanium lordotic lumbar cage 9.5mm W x 22mm L x 13mm H |
| M7391910922120 | Titanium lordotic lumbar cage 9.5mm W x 22mm L x 12mm H |
| M7391910922110 | Titanium lordotic lumbar cage 9.5mm W x 22mm L x 11mm H |
| M7391910922100 | Titanium lordotic lumbar cage 9.5mm W x 22mm L x 10mm H |
| M7391910922090 | Titanium lordotic lumbar cage 9.5mm W x 22mm L x 9mm H |
| M7391910922080 | Titanium lordotic lumbar cage 9.5mm W x 22mm L x 8mm H |
| M7391910922070 | Titanium lordotic lumbar cage 9.5mm W x 22mm L x 7mm H |
| M7391910630140 | Titanium lordotic lumbar cage 9.5mm W x 30mm L x 14mm H |
| M7391910630130 | Titanium lordotic lumbar cage 9.5mm W x 30mm L x 13mm H |
| M7391910630120 | Titanium lordotic lumbar cage 9.5mm W x 30mm L x 12mm H |
| M7391910630110 | Titanium lordotic lumbar cage 9.5mm W x 30mm L x 11mm H |
| M7391910630100 | Titanium lordotic lumbar cage 9.5mm W x 30mm L x 10mm H |
| M7391910630090 | Titanium lordotic lumbar cage 9.5mm W x 30mm L x 9mm H |
| M7391910630080 | Titanium lordotic lumbar cage 9.5mm W x 30mm L x 8mm H |
| M7391911125100 | 3D Straight Cage 25 x 10mm |
| M7391911125090 | 3D Straight Cage 25 x 9mm |
| M7391911125080 | 3D Straight Cage 25 x 8mm |
| M7391911136160 | 3D Straight Cage 36 x 16mm |
| M7391911136150 | 3D Straight Cage 36 x 15mm |
| M7391911136140 | 3D Straight Cage 36 x 14mm |
| M7391911136130 | 3D Straight Cage 36 x 13mm |
| M7391911136120 | 3D Straight Cage 36 x 12mm |
| M7391911136110 | 3D Straight Cage 36 x 11mm |
| M7391911136100 | 3D Straight Cage 36 x 10mm |
| M7391911136090 | 3D Straight Cage 36 x 9mm |
| M7391911136080 | 3D Straight Cage 36 x 8mm |
| M7391911134160 | 3D Straight Cage 34 x 16mm |
| M7391911134150 | 3D Straight Cage 34 x 15mm |
| M7391911134140 | 3D Straight Cage 34 x 14mm |
| M7391911134130 | 3D Straight Cage 34 x 13mm |
| M7391911134120 | 3D Straight Cage 34 x 12mm |
| M7391911134110 | 3D Straight Cage 34 x 11mm |
| M7391911134100 | 3D Straight Cage 34 x 10mm |
| M7391911134090 | 3D Straight Cage 34 x 9mm |
| M7391911134080 | 3D Straight Cage 34 x 8mm |
| M7391911132160 | 3D Straight Cage 32 x 16mm |
| M7391911132150 | 3D Straight Cage 32 x 15mm |
| M7391911132140 | 3D Straight Cage 32 x 14mm |
| M7391911132130 | 3D Straight Cage 32 x 13mm |
| M7391911132120 | 3D Straight Cage 32 x 12mm |
| M7391911132110 | 3D Straight Cage 32 x 11mm |