| Primary Device ID | 08806364643240 |
| NIH Device Record Key | fe4589ad-9542-46b1-b3ac-76d7050605b5 |
| Commercial Distribution Discontinuation | 2023-11-21 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Medyssey Spinal System - Deformity |
| Version Model Number | IS6535 |
| 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 | 08806364643240 [Primary] |
| MNI | Orthosis, Spinal Pedicle Fixation |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08806364643240]
Moist Heat or Steam Sterilization
[08806364643240]
Moist Heat or Steam Sterilization
[08806364643240]
Moist Heat or Steam Sterilization
[08806364643240]
Moist Heat or Steam Sterilization
[08806364643240]
Moist Heat or Steam Sterilization
[08806364643240]
Moist Heat or Steam Sterilization
[08806364643240]
Moist Heat or Steam Sterilization
[08806364643240]
Moist Heat or Steam Sterilization
[08806364643240]
Moist Heat or Steam Sterilization
[08806364643240]
Moist Heat or Steam Sterilization
[08806364643240]
Moist Heat or Steam Sterilization
[08806364643240]
Moist Heat or Steam Sterilization
[08806364643240]
Moist Heat or Steam Sterilization
[08806364643240]
Moist Heat or Steam Sterilization
[08806364643240]
Moist Heat or Steam Sterilization
[08806364643240]
Moist Heat or Steam Sterilization
[08806364643240]
Moist Heat or Steam Sterilization
[08806364643240]
Moist Heat or Steam Sterilization
[08806364643240]
Moist Heat or Steam Sterilization
[08806364643240]
Moist Heat or Steam Sterilization
[08806364643240]
Moist Heat or Steam Sterilization
[08806364643240]
Moist Heat or Steam Sterilization
[08806364643240]
Moist Heat or Steam Sterilization
[08806364643240]
Moist Heat or Steam Sterilization
[08806364643240]
Moist Heat or Steam Sterilization
[08806364643240]
Moist Heat or Steam Sterilization
[08806364643240]
Moist Heat or Steam Sterilization
[08806364643240]
Moist Heat or Steam Sterilization
[08806364643240]
Moist Heat or Steam Sterilization
[08806364643240]
Moist Heat or Steam Sterilization
[08806364643240]
Moist Heat or Steam Sterilization
[08806364643240]
Moist Heat or Steam Sterilization
[08806364643240]
Moist Heat or Steam Sterilization
[08806364643240]
Moist Heat or Steam Sterilization
[08806364643240]
Moist Heat or Steam Sterilization
[08806364643240]
Moist Heat or Steam Sterilization
[08806364643240]
Moist Heat or Steam Sterilization
[08806364643240]
Moist Heat or Steam Sterilization
[08806364643240]
Moist Heat or Steam Sterilization
[08806364643240]
Moist Heat or Steam Sterilization
[08806364643240]
Moist Heat or Steam Sterilization
[08806364643240]
Moist Heat or Steam Sterilization
[08806364643240]
Moist Heat or Steam Sterilization
[08806364643240]
Moist Heat or Steam Sterilization
[08806364643240]
Moist Heat or Steam Sterilization
[08806364643240]
Moist Heat or Steam Sterilization
[08806364643240]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2024-02-16 |
| Device Publish Date | 2016-08-18 |
| 08806364645374 | Open Rod-to-Rod Connector, Ø6.0mm to Ø6.0mm, 14mm Offset, 8mm Width |
| 08806364645343 | Open Rod-to-Rod Connector, Ø5.5mm to Ø5.5mm, 14mm Offset, 8mm Width |
| 08806364645305 | Open Rod-to-Rod Connector, Ø6.0mm to Ø6.0mm, 13mm Offset, 8mm Width |
| 08806364645299 | Open Rod-to-Rod Connector, Ø5.5mm to Ø5.5mm, 13mm Offset, 8mm Width |
| 08806364645275 | Open Rod-to-Rod Connector, Ø5.5mm to Ø5.5mm, 13mm Offset, 8mm Width |
| 08806364645268 | Open Rod-to-Rod Connector, Ø6.35mm to Ø6.35mm, 12mm Offset, 8mm Width |
| 08806364645190 | Open Rod-to-Rod Connector, Ø6.0mm to Ø6.0mm, 14mm Offset, 6mm Width |
| 08806364645169 | Open Rod-to-Rod Connector, Ø5.5mm to Ø5.5mm, 14mm Offset, 6mm Width |
| 08806364645121 | Open Rod-to-Rod Connector, Ø6.0mm to Ø6.0mm, 13mm Offset, 6mm Width |
| 08806364645114 | Open Rod-to-Rod Connector, Ø5.5mm to Ø5.5mm, 13mm Offset, 6mm Width |
| 08806364645091 | Open Rod-to-Rod Connector, Ø5.5mm to Ø5.5mm, 13mm Offset, 6mm Width |
| 08806364645084 | Open Rod-to-Rod Connector, Ø6.35mm to Ø6.35mm, 12mm Offset, 6mm Width |
| 08806364645015 | Open Rod-to-Rod Connector, Ø6.0mm to Ø6.0mm, 14mm Offset, 10mm Width |
| 08806364644988 | Open Rod-to-Rod Connector, Ø5.5mm to Ø5.5mm, 14mm Offset, 10mm Width |
| 08806364644940 | Open Rod-to-Rod Connector, Ø6.0mm to Ø6.0mm, 13mm Offset, 10mm Width |
| 08806364644933 | Open Rod-to-Rod Connector, Ø5.5mm to Ø5.5mm, 13mm Offset, 10mm Width |
| 08806364644919 | Open Rod-to-Rod Connector, Ø5.5mm to Ø5.5mm, 13mm Offset, 10mm Width |
| 08806364644902 | Open Rod-to-Rod Connector, Ø6.35mm to Ø6.35mm, 12mm Offset, 10mm Width |
| 08806364644834 | Open Rod-to-Rod Connector, Ø6.0mm to Ø6.35mm, 16mm Offset, 8mm Width |
| 08806364644803 | Open Rod-to-Rod Connector, Ø5.5mm to Ø6.0mm, 16mm Offset, 8mm Width |
| 08806364644766 | Open Rod-to-Rod Connector, Ø6.0mm to Ø6.0mm, 14mm Offset, 8mm Width |
| 08806364644759 | Open Rod-to-Rod Connector, Ø5.5mm to Ø6.35mm, 14mm Offset, 8mm Width |
| 08806364644735 | Open Rod-to-Rod Connector, Ø5.5mm to Ø5.5mm, 14mm Offset, 8mm Width |
| 08806364644728 | Open Rod-to-Rod Connector, Ø6.35mm to Ø6.35mm, 12mm Offset, 8mm Width |
| 08806364644650 | Open Rod-to-Rod Connector, Ø6.0mm to Ø6.35mm, 10mm Offset, 8mm Width |
| 08806364644629 | Open Rod-to-Rod Connector, Ø5.5mm to Ø6.0mm, 10mm Offset, 8mm Width |
| 08806364644582 | Open Rod-to-Rod Connector, Ø6.0mm to Ø6.0mm, 16mm Offset, 6mm Width |
| 08806364644575 | Open Rod-to-Rod Connector, Ø5.5mm to Ø6.35mm, 16mm Offset, 6mm Width |
| 08806364644551 | Open Rod-to-Rod Connector, Ø5.5mm to Ø5.5mm, 16mm Offset, 6mm Width |
| 08806364644544 | Open Rod-to-Rod Connector, Ø6.35mm to Ø6.35mm, 14mm Offset, 6mm Width |
| 08806364644476 | Open Rod-to-Rod Connector, Ø6.0mm to Ø6.35mm, 12mm Offset, 6mm Width |
| 08806364644445 | Open Rod-to-Rod Connector, Ø5.5mm to Ø6.0mm, 12mm Offset, 6mm Width |
| 08806364644407 | Open Rod-to-Rod Connector, Ø6.0mm to Ø6.0mm, 10mm Offset, 6mm Width |
| 08806364644391 | Open Rod-to-Rod Connector, Ø5.5mm to Ø6.35mm, 10mm Offset, 6mm Width |
| 08806364644377 | Open Rod-to-Rod Connector, Ø5.5mm to Ø5.5mm, 10mm Offset, 6mm Width |
| 08806364644360 | Open Rod-to-Rod Connector, Ø6.35mm to Ø6.35mm, 16mm Offset, 10mm Width |
| 08806364644292 | Open Rod-to-Rod Connector, Ø6.0mm to Ø6.35mm, 14mm Offset, 10mm Width |
| 08806364644261 | Open Rod-to-Rod Connector, Ø5.5mm to Ø6.0mm, 14mm Offset, 10mm Width |
| 08806364644223 | Open Rod-to-Rod Connector, Ø6.0mm to Ø6.0mm, 12mm Offset, 10mm Width |
| 08806364644216 | Open Rod-to-Rod Connector, Ø5.5mm to Ø6.35mm, 12mm Offset, 10mm Width |
| 08806364644193 | Open Rod-to-Rod Connector, Ø5.5mm to Ø5.5mm, 12mm Offset, 10mm Width |
| 08806364644186 | Open Rod-to-Rod Connector, Ø6.35mm to Ø6.35mm, 10mm Offset, 10mm Width |
| 08806364644117 | Four-Level Tandem Rod-to-Rod Connector, 6.0mm TO 6.35mm |
| 08806364644087 | Four-Level Tandem Rod-to-Rod Connector, 5.5mm TO 6.0mm |
| 08806364644049 | One-Level Offset Tandem Rod-to Rod Connector, Ø6.0mm to Ø6.0mm, Offset 13mm |
| 08806364644032 | One-Level Offset Tandem Rod-to-Rod Connector, Ø5.5mm to Ø6.35mm, Offset 13mm |
| 08806364644018 | One-Level Offset Tandem Rod-to Rod Connector, Ø5.5mm to Ø5.5mm, Offset 13mm |
| 08806364644001 | One-Level Offset Tandem Rod-to-Rod Connector, Ø6.35mm to Ø6.35mm, Offset 12mm |
| 08806364643936 | One-Level Offset Tandem Rod-to-Rod Connector, Ø6.0mm to Ø6.35mm, Offset 11mm |
| 08806364643905 | One-Level Offset Tandem Rod-to Rod Connector, Ø5.5mm to Ø6.0mm, Offset 11mm |