| Primary Device ID | 07290110206475 |
| NIH Device Record Key | faad54ff-646e-4da1-9f58-6161787473f1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CarboClear Lumbar Cage System |
| Version Model Number | Shaver – 13 mm |
| Catalog Number | CCLC9013 |
| Company DUNS | 649185170 |
| Company Name | CARBOFIX ORTHOPEDICS LTD |
| 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 | 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 | 1-800-408-0120 |
| usa@carbo-fix.com | |
| Phone | 1-800-408-0120 |
| usa@carbo-fix.com | |
| Phone | 1-800-408-0120 |
| usa@carbo-fix.com | |
| Phone | 1-800-408-0120 |
| usa@carbo-fix.com | |
| Phone | 1-800-408-0120 |
| usa@carbo-fix.com | |
| Phone | 1-800-408-0120 |
| usa@carbo-fix.com | |
| Phone | 1-800-408-0120 |
| usa@carbo-fix.com | |
| Phone | 1-800-408-0120 |
| usa@carbo-fix.com | |
| Phone | 1-800-408-0120 |
| usa@carbo-fix.com | |
| Phone | 1-800-408-0120 |
| usa@carbo-fix.com | |
| Phone | 1-800-408-0120 |
| usa@carbo-fix.com | |
| Phone | 1-800-408-0120 |
| usa@carbo-fix.com | |
| Phone | 1-800-408-0120 |
| usa@carbo-fix.com | |
| Phone | 1-800-408-0120 |
| usa@carbo-fix.com | |
| Phone | 1-800-408-0120 |
| usa@carbo-fix.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290110206475 [Primary] |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07290110206475]
Moist Heat or Steam Sterilization
[07290110206475]
Moist Heat or Steam Sterilization
[07290110206475]
Moist Heat or Steam Sterilization
[07290110206475]
Moist Heat or Steam Sterilization
[07290110206475]
Moist Heat or Steam Sterilization
[07290110206475]
Moist Heat or Steam Sterilization
[07290110206475]
Moist Heat or Steam Sterilization
[07290110206475]
Moist Heat or Steam Sterilization
[07290110206475]
Moist Heat or Steam Sterilization
[07290110206475]
Moist Heat or Steam Sterilization
[07290110206475]
Moist Heat or Steam Sterilization
[07290110206475]
Moist Heat or Steam Sterilization
[07290110206475]
Moist Heat or Steam Sterilization
[07290110206475]
Moist Heat or Steam Sterilization
[07290110206475]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-06-08 |
| Device Publish Date | 2020-05-31 |
| 07290110206666 | A lumbar intervertebral body fusion device |
| 07290110206659 | A lumbar intervertebral body fusion device |
| 07290110206642 | A lumbar intervertebral body fusion device |
| 07290110206543 | A lumbar intervertebral body fusion device |
| 07290110206536 | A lumbar intervertebral body fusion device |
| 07290110206529 | A lumbar intervertebral body fusion device |
| 07290110206512 | A lumbar intervertebral body fusion device |
| 07290110206505 | A lumbar intervertebral body fusion device |
| 07290110206628 | A surgical tool used for the introduction of bone graft into the intervertebral space. |
| 07290110206574 | A surgical tool used with the Implant Trials, if required, to assist in Trial removal from the d |
| 07290110206499 | A T-Handle to be used with Cage Shavers and Trials. |
| 07290110206482 | A surgical tool intended for discectomy and eroding of the lumbar cage endplate. Once rotated, t |
| 07290110206475 | A surgical tool intended for discectomy and eroding of the lumbar cage endplate. Once rotated, t |
| 07290110206468 | A surgical tool intended for discectomy and eroding of the lumbar cage endplate. Once rotated, t |
| 07290110206451 | A surgical tool intended for discectomy and eroding of the lumbar cage endplate. Once rotated, t |
| 07290110206444 | A surgical tool intended for discectomy and eroding of the lumbar cage endplate. Once rotated, t |
| 07290110206437 | A surgical tool intended for discectomy and eroding of the lumbar cage endplate. Once rotated, t |
| 07290110206420 | A surgical tool intended for discectomy and eroding of the lumbar cage endplate. Once rotated, t |
| 07290110206413 | A surgical tool intended for discectomy and eroding of the lumbar cage endplate. Once rotated, t |
| 07290110208745 | A lumbar intervertebral body fusion device |
| 07290110208738 | A lumbar intervertebral body fusion device |
| 07290110208721 | A lumbar intervertebral body fusion device |
| 07290110208714 | A lumbar intervertebral body fusion device |
| 07290110208844 | A lumbar intervertebral body fusion device |
| 07290110208837 | A lumbar intervertebral body fusion device |
| 07290110208820 | A lumbar intervertebral body fusion device |
| 07290110208813 | A lumbar intervertebral body fusion device |
| 07290110208806 | A lumbar intervertebral body fusion device |
| 07290110208790 | A lumbar intervertebral body fusion device |
| 07290110208783 | A lumbar intervertebral body fusion device |
| 07290110208776 | A lumbar intervertebral body fusion device |
| 07290110208769 | A lumbar intervertebral body fusion device |
| 07290110208752 | A lumbar intervertebral body fusion device |
| 07290110208684 | A surgical tool used for the introduction of the CarboClear Lumbar Cage into the disc space. |
| 07290110206567 | A surgical tool used for the introduction of the CarboClear Lumbar Cage into the disc space. |
| 07290110206550 | A surgical tool used for the introduction of the CarboClear Lumbar Cage into the disc space. |