| Primary Device ID | 00643169545892 |
| NIH Device Record Key | 1e8097ab-7987-477f-8602-1e241b9651c5 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | NAV2028K |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169545892 [Primary] |
| OLO | Orthopedic stereotaxic instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00643169545892]
Moist Heat or Steam Sterilization
[00643169545892]
Moist Heat or Steam Sterilization
[00643169545892]
Moist Heat or Steam Sterilization
[00643169545892]
Moist Heat or Steam Sterilization
[00643169545892]
Moist Heat or Steam Sterilization
[00643169545892]
Moist Heat or Steam Sterilization
[00643169545892]
Moist Heat or Steam Sterilization
[00643169545892]
Moist Heat or Steam Sterilization
[00643169545892]
Moist Heat or Steam Sterilization
[00643169545892]
Moist Heat or Steam Sterilization
[00643169545892]
Moist Heat or Steam Sterilization
[00643169545892]
Moist Heat or Steam Sterilization
[00643169545892]
Moist Heat or Steam Sterilization
[00643169545892]
Moist Heat or Steam Sterilization
[00643169545892]
Moist Heat or Steam Sterilization
[00643169545892]
Moist Heat or Steam Sterilization
[00643169545892]
Moist Heat or Steam Sterilization
[00643169545892]
Moist Heat or Steam Sterilization
[00643169545892]
Moist Heat or Steam Sterilization
[00643169545892]
Moist Heat or Steam Sterilization
[00643169545892]
Moist Heat or Steam Sterilization
[00643169545892]
Moist Heat or Steam Sterilization
[00643169545892]
Moist Heat or Steam Sterilization
[00643169545892]
Moist Heat or Steam Sterilization
[00643169545892]
Moist Heat or Steam Sterilization
[00643169545892]
Moist Heat or Steam Sterilization
[00643169545892]
Moist Heat or Steam Sterilization
[00643169545892]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-09-10 |
| Device Publish Date | 2016-08-29 |
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| 00199150021598 - Medtronic Reusable Instruments | 2025-08-26 DISTRACTOR X0425009 FRW FACING DUMBBELL |
| 00763000671488 - n/a | 2025-08-26 INSTRUMENT 6246041 14X11 RASP |
| 00763000856694 - VERTE-STACK® Spinal System | 2025-08-26 STRUT 6241064 ANATOMIC 16X14X5MM |
| 00763000856731 - VERTE-STACK® Spinal System | 2025-08-26 IMPLANT 6240786 ANATOMIC 18X16X7MM |
| 00763000856748 - VERTE-STACK® Spinal System | 2025-08-26 IMPLANT 6240886 ANATOMIC 18X16X8MM |
| 00763000856830 - VERTE-STACK® Spinal System | 2025-08-26 IMPLANT 6240164 ANATOMIC 16X14X11MM |
| 00763000856854 - VERTE-STACK® Spinal System | 2025-08-26 IMPLANT 6240641 ANATOMIC 14X11X6MM |