| Primary Device ID | 08809665581587 |
| NIH Device Record Key | 7e8a69fd-0471-496d-9b80-f99647e670e3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MEGA PLUS SPINE SYSTEM |
| Version Model Number | 82330-200 |
| 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 | 08809665581587 [Primary] |
| NKB | Thoracolumbosacral Pedicle Screw System |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08809665581587]
Moist Heat or Steam Sterilization
[08809665581587]
Moist Heat or Steam Sterilization
[08809665581587]
Moist Heat or Steam Sterilization
[08809665581587]
Moist Heat or Steam Sterilization
[08809665581587]
Moist Heat or Steam Sterilization
[08809665581587]
Moist Heat or Steam Sterilization
[08809665581587]
Moist Heat or Steam Sterilization
[08809665581587]
Moist Heat or Steam Sterilization
[08809665581587]
Moist Heat or Steam Sterilization
[08809665581587]
Moist Heat or Steam Sterilization
[08809665581587]
Moist Heat or Steam Sterilization
[08809665581587]
Moist Heat or Steam Sterilization
[08809665581587]
Moist Heat or Steam Sterilization
[08809665581587]
Moist Heat or Steam Sterilization
[08809665581587]
Moist Heat or Steam Sterilization
[08809665581587]
Moist Heat or Steam Sterilization
[08809665581587]
Moist Heat or Steam Sterilization
[08809665581587]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-01-07 |
| Device Publish Date | 2019-12-30 |
| 08809665582249 | LED Rod, Ø5.5 x 70-140mm |
| 08809665582232 | LED Rod, Ø5.5 x 70-70mm |
| 08809665582225 | LED Rod, Ø5.5 x 40-70mm |
| 08809665582218 | LED Rod, Ø5.5 x 40-40mm |
| 08809665582201 | LED Rod, Ø6.0 x 70-140mm |
| 08809665582195 | LED Rod, Ø6.0 x 70-70mm |
| 08809665582188 | LED Rod, Ø6.0 x 40-70mm |
| 08809665582171 | LED Rod, Ø6.0 x 40-40mm |
| 08809665582164 | Deformity Hex Rod(CoCr), Ø5.5 x 500mm |
| 08809665582157 | Deformity Hex Rod(CoCr), Ø5.5 x 400mm |
| 08809665582140 | Deformity Hex Rod(CoCr), Ø5.5 x 300mm |
| 08809665582133 | Deformity Hex Rod(CoCr), Ø6.0 x 500mm |
| 08809665582126 | Deformity Hex Rod(CoCr), Ø6.0 x 400mm |
| 08809665582119 | Deformity Hex Rod(CoCr), Ø6.0 x 300mm |
| 08809665582102 | Deformity Rod(CoCr), Ø5.5 x 500mm |
| 08809665582096 | Deformity Rod(CoCr), Ø5.5 x 400mm |
| 08809665582089 | Deformity Rod(CoCr), Ø5.5 x 300mm |
| 08809665582072 | Deformity Rod(CoCr), Ø6.0 x 500mm |
| 08809665582065 | Deformity Rod(CoCr), Ø6.0 x 400mm |
| 08809665582058 | Deformity Rod(CoCr), Ø6.0 x 300mm |
| 08809665582041 | Pre-bent Hex Rod(CoCr), Ø5.5 x 200mm |
| 08809665582034 | Pre-bent Hex Rod(CoCr), Ø5.5 x 190mm |
| 08809665582027 | Pre-bent Hex Rod(CoCr), Ø5.5 x 180mm |
| 08809665582010 | Pre-bent Hex Rod(CoCr), Ø5.5 x 170mm |
| 08809665582003 | Pre-bent Hex Rod(CoCr), Ø5.5 x 160mm |
| 08809665581990 | Pre-bent Hex Rod(CoCr), Ø5.5 x 150mm |
| 08809665581983 | Pre-bent Hex Rod(CoCr), Ø5.5 x 140mm |
| 08809665581976 | Pre-bent Hex Rod(CoCr), Ø5.5 x 130mm |
| 08809665581969 | Pre-bent Hex Rod(CoCr), Ø5.5 x 120mm |
| 08809665581952 | Pre-bent Hex Rod(CoCr), Ø5.5 x 110mm |
| 08809665581945 | Pre-bent Hex Rod(CoCr), Ø5.5 x 100mm |
| 08809665581938 | Pre-bent Hex Rod(CoCr), Ø5.5 x 90mm |
| 08809665581921 | Pre-bent Hex Rod(CoCr), Ø5.5 x 80mm |
| 08809665581914 | Pre-bent Hex Rod(CoCr), Ø5.5 x 75mm |
| 08809665581907 | Pre-bent Hex Rod(CoCr), Ø5.5 x 70mm |
| 08809665581891 | Pre-bent Hex Rod(CoCr), Ø5.5 x 65mm |
| 08809665581884 | Pre-bent Hex Rod(CoCr), Ø5.5 x 60mm |
| 08809665581877 | Pre-bent Hex Rod(CoCr), Ø5.5 x 55mm |
| 08809665581860 | Pre-bent Hex Rod(CoCr), Ø5.5 x 50mm |
| 08809665581853 | Pre-bent Hex Rod(CoCr), Ø5.5 x 45mm |
| 08809665581846 | Pre-bent Hex Rod(CoCr), Ø5.5 x 40mm |
| 08809665581839 | Pre-bent Hex Rod(CoCr), Ø5.5 x 35mm |
| 08809665581822 | Pre-bent Hex Rod(CoCr), Ø5.5 x 30mm |
| 08809665581815 | Pre-bent Hex Rod(CoCr), Ø6.0 x 200mm |
| 08809665581808 | Pre-bent Hex Rod(CoCr), Ø6.0 x 190mm |
| 08809665581792 | Pre-bent Hex Rod(CoCr), Ø6.0 x 180mm |
| 08809665581785 | Pre-bent Hex Rod(CoCr), Ø6.0 x 170mm |
| 08809665581778 | Pre-bent Hex Rod(CoCr), Ø6.0 x 160mm |
| 08809665581761 | Pre-bent Hex Rod(CoCr), Ø6.0 x 150mm |
| 08809665581754 | Pre-bent Hex Rod(CoCr), Ø6.0 x 140mm |