| Primary Device ID | 08809763481819 |
| NIH Device Record Key | cae29c08-f64c-41ad-a202-2d556c25d662 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MEGA PLUS MIS SPINE SYSTEM |
| Version Model Number | 94745-40 |
| Company DUNS | 687941818 |
| Company Name | BK MEDITECH 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08809763481819 [Primary] |
| NKB | Thoracolumbosacral Pedicle Screw System |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08809763481819]
Moist Heat or Steam Sterilization
[08809763481819]
Moist Heat or Steam Sterilization
[08809763481819]
Moist Heat or Steam Sterilization
[08809763481819]
Moist Heat or Steam Sterilization
[08809763481819]
Moist Heat or Steam Sterilization
[08809763481819]
Moist Heat or Steam Sterilization
[08809763481819]
Moist Heat or Steam Sterilization
[08809763481819]
Moist Heat or Steam Sterilization
[08809763481819]
Moist Heat or Steam Sterilization
[08809763481819]
Moist Heat or Steam Sterilization
[08809763481819]
Moist Heat or Steam Sterilization
[08809763481819]
Moist Heat or Steam Sterilization
[08809763481819]
Moist Heat or Steam Sterilization
[08809763481819]
Moist Heat or Steam Sterilization
[08809763481819]
Moist Heat or Steam Sterilization
[08809763481819]
Moist Heat or Steam Sterilization
[08809763481819]
Moist Heat or Steam Sterilization
[08809763481819]
Moist Heat or Steam Sterilization
[08809763481819]
Moist Heat or Steam Sterilization
[08809763481819]
Moist Heat or Steam Sterilization
[08809763481819]
Moist Heat or Steam Sterilization
[08809763481819]
Moist Heat or Steam Sterilization
[08809763481819]
Moist Heat or Steam Sterilization
[08809763481819]
Moist Heat or Steam Sterilization
[08809763481819]
Moist Heat or Steam Sterilization
[08809763481819]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2024-08-20 |
| Device Publish Date | 2020-09-18 |
| 08809763491887 | MIS Deformity Rod(CoCr), Ø6.0 x 250.5mm |
| 08809763491870 | MIS Deformity Rod(CoCr), Ø6.0 x 230.5mm |
| 08809763491863 | MIS Deformity Rod(CoCr), Ø6.0 x 210.5mm |
| 08809763491856 | MIS Deformity Rod(CoCr), Ø6.0 x 190.5mm |
| 08809763491849 | MIS Deformity Rod(CoCr), Ø6.0 x 170.5mm |
| 08809763491788 | MIS Pre-Bent Rod(CoCr), Ø6.0 x 510.5mm |
| 08809763491771 | MIS Pre-Bent Rod(CoCr), Ø6.0 x 460.5mm |
| 08809763491764 | MIS Pre-Bent Rod(CoCr), Ø6.0 x 410.5mm |
| 08809763491757 | MIS Pre-Bent Rod(CoCr), Ø6.0 x 360.5mm |
| 08809763491740 | MIS Pre-Bent Rod(CoCr), Ø6.0 x 310.5mm |
| 08809763491733 | MIS Pre-Bent Rod(CoCr), Ø6.0 x 300.5mm |
| 08809763491726 | MIS Pre-Bent Rod(CoCr), Ø6.0 x 290.5mm |
| 08809763491719 | MIS Pre-Bent Rod(CoCr), Ø6.0 x 280.5mm |
| 08809763491702 | MIS Pre-Bent Rod(CoCr), Ø6.0 x 270.5mm |
| 08809763491696 | MIS Pre-Bent Rod(CoCr), Ø6.0 x 260.5mm |
| 08809763491689 | MIS Pre-Bent Rod(CoCr), Ø6.0 x 250.5mm |
| 08809763491672 | MIS Pre-Bent Rod(CoCr), Ø6.0 x 240.5mm |
| 08809763491665 | MIS Pre-Bent Rod(CoCr), Ø6.0 x 230.5mm |
| 08809763491658 | MIS Pre-Bent Rod(CoCr), Ø6.0 x 220.5mm |
| 08809763491641 | MIS Pre-Bent Rod(CoCr), Ø6.0 x 210.5mm |
| 08809763491634 | MIS Pre-Bent Rod(CoCr), Ø6.0 x 200.5mm |
| 08809763491627 | MIS Pre-Bent Rod(CoCr), Ø6.0 x 190.5mm |
| 08809763491610 | MIS Pre-Bent Rod(CoCr), Ø6.0 x 180.5mm |
| 08809763491603 | MIS Pre-Bent Rod(CoCr), Ø6.0 x 170.5mm |
| 08809763491597 | MIS Pre-Bent Rod(CoCr), Ø6.0 x 160.5mm |
| 08809763491580 | MIS Pre-Bent Rod(CoCr), Ø6.0 x 150.5mm |
| 08809763491573 | MIS Pre-Bent Rod(CoCr), Ø6.0 x 140.5mm |
| 08809763491566 | MIS Pre-Bent Rod(CoCr), Ø6.0 x 130.5mm |
| 08809763491559 | MIS Pre-Bent Rod(CoCr), Ø6.0 x 120.5mm |
| 08809763491542 | MIS Pre-Bent Rod(CoCr), Ø6.0 x 110.5mm |
| 08809763491535 | MIS Pre-Bent Rod(CoCr), Ø6.0 x 105.5mm |
| 08809763491528 | MIS Pre-Bent Rod(CoCr), Ø6.0 x 100.5mm |
| 08809763491511 | MIS Pre-Bent Rod(CoCr), Ø6.0 x 95.5mm |
| 08809763491504 | MIS Pre-Bent Rod(CoCr), Ø6.0 x 90.5mm |
| 08809763491498 | MIS Pre-Bent Rod(CoCr), Ø6.0 x 85.5mm |
| 08809763491481 | MIS Pre-Bent Rod(CoCr), Ø6.0 x 80.5mm |
| 08809763491474 | MIS Pre-Bent Rod(CoCr), Ø6.0 x 75.5mm |
| 08809763491467 | MIS Pre-Bent Rod(CoCr), Ø6.0 x 70.5mm |
| 08809763491450 | MIS Pre-Bent Rod(CoCr), Ø6.0 x 65.5mm |
| 08809763491443 | MIS Pre-Bent Rod(CoCr), Ø6.0 x 60.5mm |
| 08809763491436 | MIS Pre-Bent Rod(CoCr), Ø6.0 x 55.5mm |
| 08809763491429 | MIS Pre-Bent Rod(CoCr), Ø6.0 x 50.5mm |
| 08809763491412 | MIS Pre-Bent Rod(CoCr), Ø6.0 x 45.5mm |
| 08809763491405 | MIS Pre-Bent Rod(CoCr), Ø6.0 x 40.5mm |
| 08809763491399 | MIS Pre-Bent Rod(CoCr), Ø6.0 x 35.5mm |
| 08809763491382 | MIS Pre-Bent Rod(CoCr), Ø6.0 x 30.5mm |
| 08809763491375 | MIS Pre-Bent Rod(CoCr), Ø6.0 x 25.5mm |
| 08809763490941 | MIS Rod(CoCr), Ø6.0 x 510.5mm |
| 08809763490934 | MIS Rod(CoCr), Ø6.0 x 460.5mm |
| 08809763490927 | MIS Rod(CoCr), Ø6.0 x 410.5mm |