| 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 |
| 00763000883492 - IB3D™ PL Spinal System | 2025-04-08 TRAY A24100100 IB3D PL TRAY |
| 00763000964634 - CD Horizon™ ModuLeX™ Spinal System | 2025-04-08 SHANK 55901504015 ST MDX OSTEOGR 4.0X15 |
| 00763000964641 - CD Horizon™ ModuLeX™ Spinal System | 2025-04-08 SHANK 55901504020 ST MDX OSTEOGR 4.0X20 |
| 00763000964658 - CD Horizon™ ModuLeX™ Spinal System | 2025-04-08 SHANK 55901504022 ST MDX OSTEOG 4.0X22.5 |
| 00763000964665 - CD Horizon™ ModuLeX™ Spinal System | 2025-04-08 SHANK 55901504025 ST MDX OSTEOGR 4.0X25 |
| 00763000964672 - CD Horizon™ ModuLeX™ Spinal System | 2025-04-08 SHANK 55901504027 ST MDX OSTEOG 4.0X27.5 |
| 00763000964689 - CD Horizon™ ModuLeX™ Spinal System | 2025-04-08 SHANK 55901504030 ST MDX OSTEOGR 4.0X30 |
| 00763000964696 - CD Horizon™ ModuLeX™ Spinal System | 2025-04-08 SHANK 55901504032 ST MDX OSTEOG 4.0X32.5 |