| Primary Device ID | 00763000152611 |
| NIH Device Record Key | 13ea2d83-d59e-477f-9d9a-aaff3a2df373 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 7068023 |
| Company DUNS | 830350380 |
| Company Name | MEDTRONIC SOFAMOR DANEK, INC. |
| 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 | false |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000152611 [Primary] |
| KCT | Sterilization wrap containers, trays, cassettes & other accessories |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00763000152611]
Moist Heat or Steam Sterilization
[00763000152611]
Moist Heat or Steam Sterilization
[00763000152611]
Moist Heat or Steam Sterilization
[00763000152611]
Moist Heat or Steam Sterilization
[00763000152611]
Moist Heat or Steam Sterilization
[00763000152611]
Moist Heat or Steam Sterilization
[00763000152611]
Moist Heat or Steam Sterilization
[00763000152611]
Moist Heat or Steam Sterilization
[00763000152611]
Moist Heat or Steam Sterilization
[00763000152611]
Moist Heat or Steam Sterilization
[00763000152611]
Moist Heat or Steam Sterilization
[00763000152611]
Moist Heat or Steam Sterilization
[00763000152611]
Moist Heat or Steam Sterilization
[00763000152611]
Moist Heat or Steam Sterilization
[00763000152611]
Moist Heat or Steam Sterilization
[00763000152611]
Moist Heat or Steam Sterilization
[00763000152611]
Moist Heat or Steam Sterilization
[00763000152611]
Moist Heat or Steam Sterilization
[00763000152611]
Moist Heat or Steam Sterilization
[00763000152611]
Moist Heat or Steam Sterilization
[00763000152611]
Moist Heat or Steam Sterilization
[00763000152611]
Moist Heat or Steam Sterilization
[00763000152611]
Moist Heat or Steam Sterilization
[00763000152611]
Moist Heat or Steam Sterilization
[00763000152611]
Moist Heat or Steam Sterilization
[00763000152611]
Moist Heat or Steam Sterilization
[00763000152611]
Moist Heat or Steam Sterilization
[00763000152611]
Moist Heat or Steam Sterilization
[00763000152611]
Moist Heat or Steam Sterilization
[00763000152611]
Moist Heat or Steam Sterilization
[00763000152611]
Moist Heat or Steam Sterilization
[00763000152611]
Moist Heat or Steam Sterilization
[00763000152611]
Moist Heat or Steam Sterilization
[00763000152611]
Moist Heat or Steam Sterilization
[00763000152611]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-02-14 |
| Device Publish Date | 2020-02-06 |
| 00763000794507 - CD HORIZON ESSENCE™ Spinal System | 2025-08-22 SCREW 45440007550 ESSENCE MAS 7.5X50 |
| 00763000794675 - CD HORIZON ESSENCE™ Spinal System | 2025-08-22 SCREW 45440004535 ESSENCE MAS 4.5X35 |
| 00199150026951 - Medtronic Reusable Instruments | 2025-08-19 HANDLE X0525002 RETRACTOR BLADE |
| 00199150027651 - Medtronic Reusable Instruments | 2025-08-19 ADAPTER X5598045 BREAKOFF DRIVER |
| 00763000880194 - n/a | 2025-08-19 AWL 7967082 U-JOINT |
| 00763000884499 - n/a | 2025-08-19 GUIDE 7080903 FIXED DRILL GUIDE |
| 00763000884505 - n/a | 2025-08-19 GUIDE 7080904 VARIABLE DRILL GUIDE |
| 00763000884574 - n/a | 2025-08-19 AWL 7080911 FIXED ANGLE AWL |