| Primary Device ID | 08800017248110 |
| NIH Device Record Key | 47715684-d0f3-445b-bab9-4fee9af52bb3 |
| Commercial Distribution Discontinuation | 2020-03-20 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | LOSPA IS Spinal Fixation System |
| Version Model Number | SA.223.6595 |
| Company DUNS | 688739895 |
| Company Name | Corentec Co., 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 | true |
| 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 | +82414107176 |
| sungwon.yang@corentec.com | |
| Phone | +82414107176 |
| sungwon.yang@corentec.com | |
| Phone | +82414107176 |
| sungwon.yang@corentec.com | |
| Phone | +82414107176 |
| sungwon.yang@corentec.com | |
| Phone | +82414107176 |
| sungwon.yang@corentec.com | |
| Phone | +82414107176 |
| sungwon.yang@corentec.com | |
| Phone | +82414107176 |
| sungwon.yang@corentec.com | |
| Phone | +82414107176 |
| sungwon.yang@corentec.com | |
| Phone | +82414107176 |
| sungwon.yang@corentec.com | |
| Phone | +82414107176 |
| sungwon.yang@corentec.com | |
| Phone | +82414107176 |
| sungwon.yang@corentec.com | |
| Phone | +82414107176 |
| sungwon.yang@corentec.com | |
| Phone | +82414107176 |
| sungwon.yang@corentec.com | |
| Phone | +82414107176 |
| sungwon.yang@corentec.com | |
| Phone | +82414107176 |
| sungwon.yang@corentec.com | |
| Phone | +82414107176 |
| sungwon.yang@corentec.com | |
| Phone | +82269374902 |
| ra@corentec.com | |
| Phone | +82269374902 |
| ra@corentec.com | |
| Phone | +82269374902 |
| ra@corentec.com | |
| Phone | +82269374902 |
| ra@corentec.com | |
| Phone | +82269374902 |
| ra@corentec.com | |
| Phone | +82269374902 |
| ra@corentec.com | |
| Phone | +82269374902 |
| ra@corentec.com | |
| Phone | +82269374902 |
| ra@corentec.com | |
| Phone | +82269374902 |
| ra@corentec.com | |
| Phone | +82269374902 |
| ra@corentec.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08800017248110 [Primary] |
| NKB | Thoracolumbosacral Pedicle Screw System |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08800017248110]
Moist Heat or Steam Sterilization
[08800017248110]
Moist Heat or Steam Sterilization
[08800017248110]
Moist Heat or Steam Sterilization
[08800017248110]
Moist Heat or Steam Sterilization
[08800017248110]
Moist Heat or Steam Sterilization
[08800017248110]
Moist Heat or Steam Sterilization
[08800017248110]
Moist Heat or Steam Sterilization
[08800017248110]
Moist Heat or Steam Sterilization
[08800017248110]
Moist Heat or Steam Sterilization
[08800017248110]
Moist Heat or Steam Sterilization
[08800017248110]
Moist Heat or Steam Sterilization
[08800017248110]
Moist Heat or Steam Sterilization
[08800017248110]
Moist Heat or Steam Sterilization
[08800017248110]
Moist Heat or Steam Sterilization
[08800017248110]
Moist Heat or Steam Sterilization
[08800017248110]
Moist Heat or Steam Sterilization
[08800017248110]
Moist Heat or Steam Sterilization
[08800017248110]
Moist Heat or Steam Sterilization
[08800017248110]
Moist Heat or Steam Sterilization
[08800017248110]
Moist Heat or Steam Sterilization
[08800017248110]
Moist Heat or Steam Sterilization
[08800017248110]
Moist Heat or Steam Sterilization
[08800017248110]
Moist Heat or Steam Sterilization
[08800017248110]
Moist Heat or Steam Sterilization
[08800017248110]
Moist Heat or Steam Sterilization
[08800017248110]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-03-30 |
| Device Publish Date | 2020-03-20 |
| 08800017249490 | POLYAXIAL PEDICLE SCREW II - standard type Ø6.0 X 75, Length 15.5mm |
| 08800017249483 | POLYAXIAL PEDICLE SCREW II - standard type Ø6.0 X 70, Length 15.5mm |
| 08800017249476 | POLYAXIAL PEDICLE SCREW II - standard type Ø6.0 X 65, Length 15.5mm |
| 08800017249469 | POLYAXIAL PEDICLE SCREW II - standard type Ø6.0 X 60, Length 15.5mm |
| 08800017249452 | POLYAXIAL PEDICLE SCREW II - standard type Ø6.0 X 55, Length 15.5mm |
| 08800017249445 | POLYAXIAL PEDICLE SCREW II - standard type Ø6.0 X 50, Length 15.5mm |
| 08800017249438 | POLYAXIAL PEDICLE SCREW II - standard type Ø6.0 X 45, Length 15.5mm |
| 08800017249421 | POLYAXIAL PEDICLE SCREW II - standard type Ø6.0 X 40, Length 15.5mm |
| 08800017249414 | POLYAXIAL PEDICLE SCREW II - standard type Ø6.0 X 35, Length 15.5mm |
| 08800017249407 | POLYAXIAL PEDICLE SCREW II - standard type Ø6.0 X 30, Length 15.5mm |
| 08800017249391 | POLYAXIAL PEDICLE SCREW II - standard type Ø6.0 X 25, Length 15.5mm |
| 08800017249384 | POLYAXIAL PEDICLE SCREW II - standard type Ø5.5 X 55, Length 15.5mm |
| 08800017249377 | POLYAXIAL PEDICLE SCREW II - standard type Ø5.5 X 50, Length 15.5mm |
| 08800017249360 | POLYAXIAL PEDICLE SCREW II - standard type Ø5.5 X 45, Length 15.5mm |
| 08800017249353 | POLYAXIAL PEDICLE SCREW II - standard type Ø5.5 X 40, Length 15.5mm |
| 08800017249346 | POLYAXIAL PEDICLE SCREW II - standard type Ø5.5 X 35, Length 15.5mm |
| 08800017249339 | POLYAXIAL PEDICLE SCREW II - standard type Ø5.5 X 30, Length 15.5mm |
| 08800017249322 | POLYAXIAL PEDICLE SCREW II - standard type Ø5.5 X 25, Length 15.5mm |
| 08800017249315 | POLYAXIAL PEDICLE SCREW II - standard type Ø5.5 X 20, Length 15.5mm |
| 08800017249308 | POLYAXIAL PEDICLE SCREW II - standard type Ø5.0 X 55, Length 15.5mm |
| 08800017249292 | POLYAXIAL PEDICLE SCREW II - standard type Ø5.0 X 50, Length 15.5mm |
| 08800017249285 | POLYAXIAL PEDICLE SCREW II - standard type Ø5.0 X 45, Length 15.5mm |
| 08800017249278 | POLYAXIAL PEDICLE SCREW II - standard type Ø5.0 X 40, Length 15.5mm |
| 08800017249261 | POLYAXIAL PEDICLE SCREW II - standard type Ø5.0 X 35, Length 15.5mm |
| 08800017249254 | POLYAXIAL PEDICLE SCREW II - standard type Ø5.0 X 30, Length 15.5mm |
| 08800017249247 | POLYAXIAL PEDICLE SCREW II - standard type Ø5.0 X 25, Length 15.5mm |
| 08800017249230 | POLYAXIAL PEDICLE SCREW II - standard type Ø5.0 X 20, Length 15.5mm |
| 08800017249223 | POLYAXIAL PEDICLE SCREW II - standard type Ø4.5 X 55, Length 15.5mm |
| 08800017249216 | POLYAXIAL PEDICLE SCREW II - standard type Ø4.5 X 50, Length 15.5mm |
| 08800017249209 | POLYAXIAL PEDICLE SCREW II - standard type Ø4.5 X 45, Length 15.5mm |
| 08800017249193 | POLYAXIAL PEDICLE SCREW II - standard type Ø4.5 X 40, Length 15.5mm |
| 08800017249186 | POLYAXIAL PEDICLE SCREW II - standard type Ø4.5 X 35, Length 15.5mm |
| 08800017249179 | POLYAXIAL PEDICLE SCREW II - standard type Ø4.5 X 30, Length 15.5mm |
| 08800017249162 | POLYAXIAL PEDICLE SCREW II - standard type Ø4.5 X 25, Length 15.5mm |
| 08800017249155 | POLYAXIAL PEDICLE SCREW II - standard type Ø4.5 X 20, Length 15.5mm |
| 08800017249148 | POLYAXIAL PEDICLE SCREW II - standard type Ø4.0 X 55, Length 15.5mm |
| 08800017259086 | POLYAXIAL GUIDED PEDICLE SCREW II - Guided type Ø9.5 X 140, Length 28.2mm |
| 08800017259079 | POLYAXIAL GUIDED PEDICLE SCREW II - Guided type Ø9.5 X 135, Length 28.2mm |
| 08800017259062 | POLYAXIAL GUIDED PEDICLE SCREW II - Guided type Ø9.5 X 130, Length 28.2mm |
| 08800017259055 | POLYAXIAL GUIDED PEDICLE SCREW II - Guided type Ø9.5 X 125, Length 28.2mm |
| 08800017259048 | POLYAXIAL GUIDED PEDICLE SCREW II - Guided type Ø9.5 X 120, Length 28.2mm |
| 08800017259031 | POLYAXIAL GUIDED PEDICLE SCREW II - Guided type Ø9.5 X 115, Length 28.2mm |
| 08800017259024 | POLYAXIAL GUIDED PEDICLE SCREW II - Guided type Ø9.5 X 110, Length 28.2mm |
| 08800017259017 | POLYAXIAL GUIDED PEDICLE SCREW II - Guided type Ø9.5 X 105, Length 28.2mm |
| 08800017259000 | POLYAXIAL GUIDED PEDICLE SCREW II - Guided type Ø9.5 X 100, Length 28.2mm |
| 08800017258997 | POLYAXIAL GUIDED PEDICLE SCREW II - Guided type Ø9.5 X 95, Length 28.2mm |
| 08800017258980 | POLYAXIAL GUIDED PEDICLE SCREW II - Guided type Ø9.5 X 90, Length 28.2mm |
| 08800017258973 | POLYAXIAL GUIDED PEDICLE SCREW II - Guided type Ø9.5 X 85, Length 28.2mm |
| 08800017258966 | POLYAXIAL GUIDED PEDICLE SCREW II - Guided type Ø9.5 X 80, Length 28.2mm |
| 08800017258959 | POLYAXIAL GUIDED PEDICLE SCREW II - Guided type Ø9.5 X 75, Length 28.2mm |