| Primary Device ID | 07290110208653 |
| NIH Device Record Key | eb458de8-ea2f-42e3-b261-b19e26245861 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CarboClear Cervical Plate System |
| Version Model Number | Patient Specific Cervical Plate |
| Catalog Number | SP0002 |
| 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 | 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 | 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 | |
| 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 | 07290110208653 [Primary] |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-12-11 |
| Device Publish Date | 2020-12-03 |
| 07290110207342 | Self-drilling screw for use with CarboClear Cervical Plate. |
| 07290110207335 | Self-drilling screw for use with CarboClear Cervical Plate. |
| 07290110207328 | Self-drilling screw for use with CarboClear Cervical Plate. |
| 07290110207311 | Self-drilling screw for use with CarboClear Cervical Plate. |
| 07290110207304 | Self-drilling screw for use with CarboClear Cervical Plate. |
| 07290110207298 | Self-drilling screw for use with CarboClear Cervical Plate. |
| 07290110207281 | Self-drilling screw for use with CarboClear Cervical Plate. |
| 07290110207274 | Self-drilling screw for use with CarboClear Cervical Plate. |
| 07290110207267 | Self-drilling screw for use with CarboClear Cervical Plate. |
| 07290110207250 | Self-drilling screw for use with CarboClear Cervical Plate. |
| 07290110207243 | Self-drilling screw for use with CarboClear Cervical Plate. |
| 07290110207236 | Sterilization case for use with the CarboClear Cervical Plate System. |
| 07290110207229 | Intended to assist in determining the required plate length during operation. |
| 07290110207212 | Following screw hole preparation, where applicable, the gauge may be used to measure depth and t |
| 07290110207205 | Intended for locking the drill bits stopper in place. |
| 07290110207199 | Used to prepare the screw canal in combination with the Cervical Drill Guide. |
| 07290110207182 | Used to prepare the screw canal in combination with the Cervical Drill Guide. |
| 07290110207175 | Used to direct the drill bit to prepare the screw pathway. |
| 07290110207168 | Used to gain access through the bone cortex. |
| 07290110207151 | Used to hold the plate during screw hole preparation. |
| 07290110207144 | Used to securely hold the plate for proper placement and positioning. |
| 07290110208554 | Used to securely hold the plate for proper placement and positioning. |
| 07290110208547 | Used to securely hold the plate for proper placement and positioning. |
| 07290110208653 | Patient-Specific anterior fixation cervical plate |
| 07290110207137 | Anterior fixation cervical plate |
| 07290110207120 | Anterior fixation cervical plate |
| 07290110207113 | Anterior fixation cervical plate |
| 07290110207106 | Anterior fixation cervical plate |
| 07290110207090 | Anterior fixation cervical plate |
| 07290110207083 | Anterior fixation cervical plate |
| 07290110207076 | Anterior fixation cervical plate |
| 07290110207069 | Anterior fixation cervical plate |
| 07290110207052 | Anterior fixation cervical plate |
| 07290110207045 | Anterior fixation cervical plate |
| 07290110207038 | Anterior fixation cervical plate |
| 07290110207021 | Anterior fixation cervical plate |
| 07290110207014 | Anterior fixation cervical plate |
| 07290110207007 | Anterior fixation cervical plate |
| 07290110206994 | Anterior fixation cervical plate |
| 07290110206987 | Anterior fixation cervical plate |
| 07290110206970 | Anterior fixation cervical plate |
| 07290110206963 | Anterior fixation cervical plate |
| 07290110206956 | Anterior fixation cervical plate |
| 07290110206949 | Anterior fixation cervical plate |
| 07290110206932 | Anterior fixation cervical plate |
| 07290110206925 | Anterior fixation cervical plate |
| 07290110206918 | Anterior fixation cervical plate |
| 07290110206901 | Anterior fixation cervical plate |
| 07290110206895 | Anterior fixation cervical plate |
| 07290117353707 | Used to prepare the screw canal |