| Primary Device ID | 07290110208967 |
| NIH Device Record Key | 202e0afc-36d2-437b-b29a-41f63361ae59 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CarboClear Cervical Cage / VBR System |
| Version Model Number | Implant Trial H=4 |
| Catalog Number | PL940390 |
| 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 | |
| Phone | 1-800-408-0120 |
| usa@carbo-fix.com | |
| Phone | 1-800-408-0120 |
| usa@carbo-fix.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290110208967 [Primary] |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07290110208967]
Moist Heat or Steam Sterilization
[07290110208967]
Moist Heat or Steam Sterilization
[07290110208967]
Moist Heat or Steam Sterilization
[07290110208967]
Moist Heat or Steam Sterilization
[07290110208967]
Moist Heat or Steam Sterilization
[07290110208967]
Moist Heat or Steam Sterilization
[07290110208967]
Moist Heat or Steam Sterilization
[07290110208967]
Moist Heat or Steam Sterilization
[07290110208967]
Moist Heat or Steam Sterilization
[07290110208967]
Moist Heat or Steam Sterilization
[07290110208967]
Moist Heat or Steam Sterilization
[07290110208967]
Moist Heat or Steam Sterilization
[07290110208967]
Moist Heat or Steam Sterilization
[07290110208967]
Moist Heat or Steam Sterilization
[07290110208967]
Moist Heat or Steam Sterilization
[07290110208967]
Moist Heat or Steam Sterilization
[07290110208967]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-09-26 |
| Device Publish Date | 2023-09-18 |
| 07290117351260 | A surgical tool intended to prepare the endplates of the adjacent vertebrae prior to implant ins |
| 07290117351253 | A surgical tool used with the Implant Trials, if required, to assist in Trial removal from the d |
| 07290110209001 | A surgical tool for use with the Cervical Cage / VBR devices. The Implant Trial is intended for |
| 07290110208998 | A surgical tool for use with the Cervical Cage / VBR devices. The Implant Trial is intended for |
| 07290110208981 | A surgical tool for use with the Cervical Cage / VBR devices. The Implant Trial is intended for |
| 07290110208974 | A surgical tool for use with the Cervical Cage / VBR devices. The Implant Trial is intended for |
| 07290110208967 | A surgical tool for use with the Cervical Cage / VBR devices. The Implant Trial is intended for |
| 07290110208950 | A surgical tool intended to assist in cage positioning within the disc space when required |
| 07290110208943 | Insertion Handle for use with the CarboClear Cervical Cage / VBR |
| 07290110208936 | Insertion Handle for use with the CarboClear Cervical Cage / VBR |
| 07290110208929 | Insertion Handle for use with the CarboClear Cervical Cage |
| 07290110208912 | Insertion Handle for use with the CarboClear Cervical Cage |