| Primary Device ID | 08806364621064 |
| NIH Device Record Key | 39273c72-84f5-451f-b651-dbd83b8b369d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Kora Spinal System |
| Version Model Number | MMO9570 |
| Company DUNS | 688211503 |
| Company Name | Medyssey 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08806364621064 [Primary] |
| MNI | Orthosis, Spinal Pedicle Fixation |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08806364621064]
Moist Heat or Steam Sterilization
[08806364621064]
Moist Heat or Steam Sterilization
[08806364621064]
Moist Heat or Steam Sterilization
[08806364621064]
Moist Heat or Steam Sterilization
[08806364621064]
Moist Heat or Steam Sterilization
[08806364621064]
Moist Heat or Steam Sterilization
[08806364621064]
Moist Heat or Steam Sterilization
[08806364621064]
Moist Heat or Steam Sterilization
[08806364621064]
Moist Heat or Steam Sterilization
[08806364621064]
Moist Heat or Steam Sterilization
[08806364621064]
Moist Heat or Steam Sterilization
[08806364621064]
Moist Heat or Steam Sterilization
[08806364621064]
Moist Heat or Steam Sterilization
[08806364621064]
Moist Heat or Steam Sterilization
[08806364621064]
Moist Heat or Steam Sterilization
[08806364621064]
Moist Heat or Steam Sterilization
[08806364621064]
Moist Heat or Steam Sterilization
[08806364621064]
Moist Heat or Steam Sterilization
[08806364621064]
Moist Heat or Steam Sterilization
[08806364621064]
Moist Heat or Steam Sterilization
[08806364621064]
Moist Heat or Steam Sterilization
[08806364621064]
Moist Heat or Steam Sterilization
[08806364621064]
Moist Heat or Steam Sterilization
[08806364621064]
Moist Heat or Steam Sterilization
[08806364621064]
Moist Heat or Steam Sterilization
[08806364621064]
Moist Heat or Steam Sterilization
[08806364621064]
Moist Heat or Steam Sterilization
[08806364621064]
Moist Heat or Steam Sterilization
[08806364621064]
Moist Heat or Steam Sterilization
[08806364621064]
Moist Heat or Steam Sterilization
[08806364621064]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2023-06-22 |
| Device Publish Date | 2016-08-19 |
| 08806364647613 | Monoaxial Pedicle Screw, Ø6.5mm X 20mm , Ø6.0mm Rod |
| 08806364621064 | Monoaxial Pedicle Screw, Ø9.5mm X 70mm , Ø6.0mm Rod |
| 08809214542359 | Reduction Polyaxial Pedicle Screw, Ø5.0mm X 45mm, Ø6.0mm Rod |
| 08809214542342 | Reduction Polyaxial Pedicle Screw, Ø5.0mm X 40mm, Ø6.0mm Rod |
| 08809214542335 | Reduction Polyaxial Pedicle Screw, Ø5.0mm X 35mm, Ø6.0mm Rod |
| 08809214542328 | Reduction Polyaxial Pedicle Screw, Ø5.0mm X 30mm, Ø6.0mm Rod |
| 08809214542311 | Reduction Polyaxial Pedicle Screw, Ø5.0mm X 25mm, Ø6.0mm Rod |
| 08809214542304 | Reduction Polyaxial Pedicle Screw, Ø5.0mm X 20mm, Ø6.0mm Rod |
| 08809214542267 | Reduction Polyaxial Pedicle Screw, Ø4.5mm X 45mm, Ø6.0mm Rod |
| 08809214542250 | Reduction Polyaxial Pedicle Screw, Ø4.5mm X 40mm, Ø6.0mm Rod |
| 08809214542243 | Reduction Polyaxial Pedicle Screw, Ø4.5mm X 35mm, Ø6.0mm Rod |
| 08809214542236 | Reduction Polyaxial Pedicle Screw, Ø4.5mm X 30mm, Ø6.0mm Rod |
| 08809214542229 | Reduction Polyaxial Pedicle Screw, Ø4.5mm X 25mm, Ø6.0mm Rod |
| 08809214542212 | Reduction Polyaxial Pedicle Screw, Ø4.5mm X 20mm, Ø6.0mm Rod |
| 08809214542205 | Reduction Polyaxial Pedicle Screw, Ø4.0mm X 40mm, Ø6.0mm Rod |
| 08809214542199 | Reduction Polyaxial Pedicle Screw, Ø4.0mm X 35mm, Ø6.0mm Rod |
| 08809214542182 | Reduction Polyaxial Pedicle Screw, Ø4.0mm X 30mm, Ø6.0mm Rod |
| 08809214542175 | Reduction Polyaxial Pedicle Screw, Ø4.0mm X 25mm, Ø6.0mm Rod |
| 08809214542168 | Reduction Polyaxial Pedicle Screw, Ø4.0mm X 20mm, Ø6.0mm Rod |
| 08809214541482 | Reduction Monoaxial Pedicle Screw, Ø5.0mm X 45mm, Ø6.0mm Rod |
| 08809214541475 | Reduction Monoaxial Pedicle Screw, Ø5.0mm X 40mm, Ø6.0mm Rod |
| 08809214541468 | Reduction Monoaxial Pedicle Screw, Ø5.0mm X 35mm, Ø6.0mm Rod |
| 08809214541451 | Reduction Monoaxial Pedicle Screw, Ø5.0mm X 30mm, Ø6.0mm Rod |
| 08809214541444 | Reduction Monoaxial Pedicle Screw, Ø5.0mm X 25mm, Ø6.0mm Rod |
| 08809214541437 | Reduction Monoaxial Pedicle Screw, Ø5.0mm X 20mm, Ø6.0mm Rod |
| 08809214541390 | Reduction Monoaxial Pedicle Screw, Ø4.5mm X 45mm, Ø6.0mm Rod |
| 08809214541383 | Reduction Monoaxial Pedicle Screw, Ø4.5mm X 40mm, Ø6.0mm Rod |
| 08809214541376 | Reduction Monoaxial Pedicle Screw, Ø4.5mm X 35mm, Ø6.0mm Rod |
| 08809214541369 | Reduction Monoaxial Pedicle Screw, Ø4.5mm X 30mm, Ø6.0mm Rod |
| 08809214541352 | Reduction Monoaxial Pedicle Screw, Ø4.5mm X 25mm, Ø6.0mm Rod |
| 08809214541345 | Reduction Monoaxial Pedicle Screw, Ø4.5mm X 20mm, Ø6.0mm Rod |
| 08809214541338 | Reduction Monoaxial Pedicle Screw, Ø4.0mm X 40mm, Ø6.0mm Rod |
| 08809214541321 | Reduction Monoaxial Pedicle Screw, Ø4.0mm X 35mm, Ø6.0mm Rod |
| 08809214541314 | Reduction Monoaxial Pedicle Screw, Ø4.0mm X 30mm, Ø6.0mm Rod |
| 08809214541307 | Reduction Monoaxial Pedicle Screw, Ø4.0mm X 25mm, Ø6.0mm Rod |
| 08809214541291 | Reduction Monoaxial Pedicle Screw, Ø4.0mm X 20mm, Ø6.0mm Rod |
| 08806364692361 | Polyaxial Pedicle Screw, Ø5.0mm X 45mm, Ø6.0mm Rod |
| 08806364692354 | Polyaxial Pedicle Screw, Ø5.0mm X 40mm, Ø6.0mm Rod |
| 08806364692347 | Polyaxial Pedicle Screw, Ø5.0mm X 35mm, Ø6.0mm Rod |
| 08806364692330 | Polyaxial Pedicle Screw, Ø5.0mm X 30mm, Ø6.0mm Rod |
| 08806364692323 | Polyaxial Pedicle Screw, Ø5.0mm X 25mm, Ø6.0mm Rod |
| 08806364692316 | Polyaxial Pedicle Screw, Ø5.0mm X 20mm, Ø6.0mm Rod |
| 08806364692279 | Polyaxial Pedicle Screw, Ø4.5mm X 45mm, Ø6.0mm Rod |
| 08806364692262 | Polyaxial Pedicle Screw, Ø4.5mm X 40mm, Ø6.0mm Rod |
| 08806364692255 | Polyaxial Pedicle Screw, Ø4.5mm X 35mm, Ø6.0mm Rod |
| 08806364692248 | Polyaxial Pedicle Screw, Ø4.5mm X 30mm, Ø6.0mm Rod |
| 08806364692231 | Polyaxial Pedicle Screw, Ø4.5mm X 25mm, Ø6.0mm Rod |
| 08806364692224 | Polyaxial Pedicle Screw, Ø4.5mm X 20mm, Ø6.0mm Rod |
| 08806364692217 | Polyaxial Pedicle Screw, Ø4.0mm X 40mm, Ø6.0mm Rod |
| 08806364692200 | Polyaxial Pedicle Screw, Ø4.0mm X 35mm, Ø6.0mm Rod |