| Primary Device ID | 00763000152598 |
| NIH Device Record Key | baeaf46a-c9ac-4a69-accd-67b70a4211a9 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 7068021 |
| 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 | 00763000152598 [Primary] |
| KCT | Sterilization wrap containers, trays, cassettes & other accessories |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00763000152598]
Moist Heat or Steam Sterilization
[00763000152598]
Moist Heat or Steam Sterilization
[00763000152598]
Moist Heat or Steam Sterilization
[00763000152598]
Moist Heat or Steam Sterilization
[00763000152598]
Moist Heat or Steam Sterilization
[00763000152598]
Moist Heat or Steam Sterilization
[00763000152598]
Moist Heat or Steam Sterilization
[00763000152598]
Moist Heat or Steam Sterilization
[00763000152598]
Moist Heat or Steam Sterilization
[00763000152598]
Moist Heat or Steam Sterilization
[00763000152598]
Moist Heat or Steam Sterilization
[00763000152598]
Moist Heat or Steam Sterilization
[00763000152598]
Moist Heat or Steam Sterilization
[00763000152598]
Moist Heat or Steam Sterilization
[00763000152598]
Moist Heat or Steam Sterilization
[00763000152598]
Moist Heat or Steam Sterilization
[00763000152598]
Moist Heat or Steam Sterilization
[00763000152598]
Moist Heat or Steam Sterilization
[00763000152598]
Moist Heat or Steam Sterilization
[00763000152598]
Moist Heat or Steam Sterilization
[00763000152598]
Moist Heat or Steam Sterilization
[00763000152598]
Moist Heat or Steam Sterilization
[00763000152598]
Moist Heat or Steam Sterilization
[00763000152598]
Moist Heat or Steam Sterilization
[00763000152598]
Moist Heat or Steam Sterilization
[00763000152598]
Moist Heat or Steam Sterilization
[00763000152598]
Moist Heat or Steam Sterilization
[00763000152598]
Moist Heat or Steam Sterilization
[00763000152598]
Moist Heat or Steam Sterilization
[00763000152598]
Moist Heat or Steam Sterilization
[00763000152598]
Moist Heat or Steam Sterilization
[00763000152598]
Moist Heat or Steam Sterilization
[00763000152598]
Moist Heat or Steam Sterilization
[00763000152598]
Moist Heat or Steam Sterilization
[00763000152598]
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 |
| 00643169571839 - RIALTO™ SI FUSION SYSTEM | 2025-05-16 DEVICE 74200001245 THREADED 12X45 |
| 00763000880101 - n/a | 2025-05-16 INSERTER 7967012 CP |
| 00643169500365 - CD HORIZON® Growth Rod Conversion Set | 2025-05-13 CONNECTOR 811212GR 110MM TI 5.5MM ROD S |
| 00763000878016 - n/a | 2025-05-13 RASP 6630919 PARALLEL 10MMX15MMX12MM |
| 00763000878047 - n/a | 2025-05-13 RASP 6630916 PARALLEL 7MMX15MMX12MM |
| 00763000891367 - CD Horizon™ ModuLeX™ Spinal System | 2025-05-13 SHANK 55900608510 ILIAC 8.5X110MM |
| 00763000891381 - CD Horizon™ ModuLeX™ Spinal System | 2025-05-13 SHANK 55900608560 ILIAC 8.5X60MM |
| 00763000280468 - CENTERPIECE™ Plate Fixation System | 2025-05-12 TRAY 8530107R CENTERPIECE INSTRUMENTS |