| Primary Device ID | B565G20015000 |
| NIH Device Record Key | 7d01e200-2574-4025-a415-e3743ac315b7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fuse Pedicle Screw System |
| Version Model Number | G200150 |
| Catalog Number | G200150 |
| Company DUNS | 017138000 |
| Company Name | CPM MEDICAL CONSULTANTS, LLC |
| 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 | 972-331-5860 |
| xx@xx.xx | |
| Phone | 972-331-5860 |
| xx@xx.xx | |
| Phone | 972-331-5860 |
| xx@xx.xx | |
| Phone | 972-331-5860 |
| xx@xx.xx | |
| Phone | 972-331-5860 |
| xx@xx.xx | |
| Phone | 972-331-5860 |
| xx@xx.xx | |
| Phone | 972-331-5860 |
| xx@xx.xx | |
| Phone | 972-331-5860 |
| xx@xx.xx | |
| Phone | 972-331-5860 |
| xx@xx.xx | |
| Phone | 972-331-5860 |
| xx@xx.xx | |
| Phone | 972-331-5860 |
| xx@xx.xx |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B565G20015000 [Primary] |
| NKB | Thoracolumbosacral Pedicle Screw System |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B565G20015000]
Moist Heat or Steam Sterilization
[B565G20015000]
Moist Heat or Steam Sterilization
[B565G20015000]
Moist Heat or Steam Sterilization
[B565G20015000]
Moist Heat or Steam Sterilization
[B565G20015000]
Moist Heat or Steam Sterilization
[B565G20015000]
Moist Heat or Steam Sterilization
[B565G20015000]
Moist Heat or Steam Sterilization
[B565G20015000]
Moist Heat or Steam Sterilization
[B565G20015000]
Moist Heat or Steam Sterilization
[B565G20015000]
Moist Heat or Steam Sterilization
[B565G20015000]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-05-06 |
| Device Publish Date | 2024-04-26 |
| B565FZTC6555CA1 | 6.5 mm x 55 mm Tall Cannulated Polyaxial Pedicle Screw |
| B565FZTC6550CA1 | 6.5 mm x 50 mm Tall Cannulated Polyaxial Pedicle Screw |
| B565FZTC6545CA1 | 6.5 mm x 45 mm Tall Cannulated Polyaxial Pedicle Screw |
| B565FZTC6540CA1 | 6.5 mm x 40 mm Tall Cannulated Polyaxial Pedicle Screw |
| B565FZTC6535CA1 | 6.5 mm x 35 mm Tall Cannulated Polyaxial Pedicle Screw |
| B565FZTC6530CA1 | 6.5 mm x 30 mm Tall Cannulated Polyaxial Pedicle Screw |
| B565FZTC5550CA1 | 5.5 mm x 50 mm Tall Cannulated Polyaxial Pedicle Screw |
| B565FZTC5545CA1 | 5.5 mm x 45 mm Tall Cannulated Polyaxial Pedicle Screw |
| B565FZTC5540CA1 | 5.5 mm x 40 mm Tall Cannulated Polyaxial Pedicle Screw |
| B565FZTC5535CA1 | 5.5 mm x 35 mm Tall Cannulated Polyaxial Pedicle Screw |
| B565FZSC1001 | Set Caps |
| B565FZMN7555A1 | 7.5mm x 55mm MID TOP Screw Non-Cannulated |
| B565FZMN7550A1 | 7.5mm x 50mm MID TOP Screw Non-Cannulated |
| B565FZMN7545A1 | 7.5mm x 45mm MID TOP Screw Non-Cannulated |
| B565FZMN7540A1 | 7.5mm x 40mm MID TOP Screw Non-Cannulated |
| B565FZMN7535A1 | 7.5mm x 35mm MID TOP Screw Non-Cannulated |
| B565FZMN7530A1 | 7.5mm x 30mm MID TOP Screw Non-Cannulated |
| B565FZMN6555A1 | 6.5mm x 55mm MID TOP Screw Non-Cannulated |
| B565FZMN6550A1 | 6.5mm x 50mm MID TOP Screw Non-Cannulated |
| B565FZMN6545A1 | 6.5 mm x 45 mm MID TOP Screw Non-Cannulated |
| B565FZMN6540A1 | 6.5 mm x 40 mm MID TOP Screw Non-Cannulated |
| B565FZMN6535A1 | 6.5 mm x 35 mm MID TOP Screw Non-Cannulated |
| B565FZMN6530A1 | 6.5 mm x 30 mm MID TOP Screw Non-Cannulated |
| B565FZMN5550A1 | 5.5 mm x 50 mm MID TOP Screw Non-Cannulated |
| B565FZMN5545A1 | 5.5 mm x 45 mm MID TOP Screw Non-Cannulated |
| B565FZMN5540A1 | 5.5 mm x 40 mm MID TOP Screw Non-Cannulated |
| B565FZMN5535A1 | 5.5 mm x 35 mm MID TOP Screw Non-Cannulated |
| B565FZMN5530A1 | 5.5 mm x 30 mm MID TOP Screw Non-Cannulated |
| B565FZMN5525A1 | 5.5 mm x 25 mm MID TOP Screw Non-Cannulated |
| B565FZMC55951 | 5.5 mm x 95 mm MIS Curved Rod |
| B565FZMC55901 | 5.5 mm x 90 mm MIS Curved Rod |
| B565FZMC55851 | 5.5 mm x 85 mm MIS Curved Rod |
| B565FZMC55801 | 5.5 mm x 80 mm MIS Curved Rod |
| B565FZMC55751 | 5.5 mm x 75 mm MIS Curved Rod |
| B565FZMC55701 | 5.5 mm x 70 mm MIS Curved Rod |
| B565FZMC55651 | 5.5 mm x 65 mm MIS Curved Rod |
| B565FZMC55601 | 5.5 mm x 60 mm MIS Curved Rod |
| B565FZMC55551 | 5.5 mm x 55 mm MIS Curved Rod |
| B565FZMC55501 | 5.5 mm x 50 mm MIS Curved Rod |
| B565FZMC55451 | 5.5 mm x 45 mm MIS Curved Rod |
| B565FZMC55401 | 5.5 mm x 40 mm MIS Curved Rod |
| B565FZMC551501 | 5.5 mm x 150 mm MIS Curved Rod |
| B565FZMC551401 | 5.5 mm x 140 mm MIS Curved Rod |
| B565FZMC551301 | 5.5 mm x 130 mm MIS Curved Rod |
| B565FZMC551201 | 5.5 mm x 120 mm MIS Curved Rod |
| B565FZMC551101 | 5.5 mm x 110 mm MIS Curved Rod |
| B565FZMC551001 | 5.5 mm x 100 mm MIS Curved Rod |
| B565FZLN7555CA1 | 7.5 mm x 55 mm Low-Top Polyaxial Pedicle Screw Cannulated |
| B565FZLN7550CA1 | 7.5 mm x 50 mm Low-Top Polyaxial Pedicle Screw Cannulated |
| B565FZLN7545CA1 | 7.5 mm x 45 mm Low-Top Polyaxial Pedicle Screw Cannulated |