| Primary Device ID | 00763000255275 |
| NIH Device Record Key | 2fe00d89-7ac7-495e-aa73-90230fd1f3fa |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Catalyft PL Expandable Interbody System |
| Version Model Number | NAV6062076 |
| 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 | 00763000255275 [Primary] |
| MAX | Intervertebral fusion device with bone graft, lumbar |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00763000255275]
Moist Heat or Steam Sterilization
[00763000255275]
Moist Heat or Steam Sterilization
[00763000255275]
Moist Heat or Steam Sterilization
[00763000255275]
Moist Heat or Steam Sterilization
[00763000255275]
Moist Heat or Steam Sterilization
[00763000255275]
Moist Heat or Steam Sterilization
[00763000255275]
Moist Heat or Steam Sterilization
[00763000255275]
Moist Heat or Steam Sterilization
[00763000255275]
Moist Heat or Steam Sterilization
[00763000255275]
Moist Heat or Steam Sterilization
[00763000255275]
Moist Heat or Steam Sterilization
[00763000255275]
Moist Heat or Steam Sterilization
[00763000255275]
Moist Heat or Steam Sterilization
[00763000255275]
Moist Heat or Steam Sterilization
[00763000255275]
Moist Heat or Steam Sterilization
[00763000255275]
Moist Heat or Steam Sterilization
[00763000255275]
Moist Heat or Steam Sterilization
[00763000255275]
Moist Heat or Steam Sterilization
[00763000255275]
Moist Heat or Steam Sterilization
[00763000255275]
Moist Heat or Steam Sterilization
[00763000255275]
Moist Heat or Steam Sterilization
[00763000255275]
Moist Heat or Steam Sterilization
[00763000255275]
Moist Heat or Steam Sterilization
[00763000255275]
Moist Heat or Steam Sterilization
[00763000255275]
Moist Heat or Steam Sterilization
[00763000255275]
Moist Heat or Steam Sterilization
[00763000255275]
Moist Heat or Steam Sterilization
[00763000255275]
Moist Heat or Steam Sterilization
[00763000255275]
Moist Heat or Steam Sterilization
[00763000255275]
Moist Heat or Steam Sterilization
[00763000255275]
Moist Heat or Steam Sterilization
[00763000255275]
Moist Heat or Steam Sterilization
[00763000255275]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-06-24 |
| Device Publish Date | 2021-06-16 |
| 00763000292195 | VERIFICATION TOOL NAV6061013 NAV INSERTR |
| 00763000255299 | TRIAL NAV6062116 CATALYFT PL40 NAV 11MM |
| 00763000255282 | TRIAL NAV6062096 CATALYFT PL40 NAV 9MM |
| 00763000255275 | TRIAL NAV6062076 CATALYFT PL40 NAV 7MM |
| 00763000255268 | TRIAL NAV6061116 CATALYFT PL NAV 11MM |
| 00763000255251 | TRIAL NAV6061096 CATALYFT PL NAV 9MM |
| 00763000255244 | TRIAL NAV6061076 CATALYFT PL NAV 7MM |
| 00763000255237 | INSERTER NAV6061000 CATALYFT PL NAV |
| 00763000253554 | DRIVER 6061002 CATALYFT PL INSERTER |
| 00763000253547 | INSERTER 6061001 CATALYFT PL INNER SLV |
| 00763000253530 | INSERTER 6061000 CATALYFT PL OUTER |
| 00763000246853 | SPACER 6069116 CATALYFT PL40 LONG 11MM |
| 00763000246846 | PACER 6069113 CATALYFT PL40 SHORT 11MM |
| 00763000246822 | SPACER 6069096 CATALYFT PL40 LONG 9MM |
| 00763000246815 | SPACER 6069093 CATALYFT PL40 SHORT 9MM |
| 00763000246792 | SPACER 6069076 CATALYFT PL40 LONG 7MM |
| 00763000246785 | SPACER 6069073 CATALYFT PL40 SHORT 7MM |
| 00763000246761 | SPACER 6068116 CATALYFT PL LONG 11MM |
| 00763000246754 | SPACER 6068113 CATALYFT PL SHORT 11MM |
| 00763000246730 | SPACER 6068096 CATALYFT PL LONG 9MM |
| 00763000246723 | SPACER 6068093 CATALYFT PL SHORT 9MM |
| 00763000246709 | SPACER 6068076 CATALYFT PL LONG 7MM |
| 00763000246693 | SPACER 6068073 CATALYFT PL SHORT 7MM |
| 00763000246518 | TRAY 6060003 CATALYFT PL NAV INNER TRAY |
| 00763000239374 | TRIAL 6062116 CATALYFT PL40 11MM |
| 00763000239367 | TRIAL 6062096 CATALYFT PL40 9MM |
| 00763000239350 | TRIAL 6062076 CATALYFT PL40 7MM |
| 00763000239343 | TRIAL 6061116 CATALYFT PL 11MM |
| 00763000239336 | TRIAL 6061096 CATALYFT PL 9MM |
| 00763000239329 | TRIAL 6061076 CATALYFT PL 7MM |
| 00763000229221 | TRAY 6060001 CATALYFT PL INSTRUMENTS |
| 00763000229214 | CASE 6060000 CATALYFT PL NAV INSTRUMENTS |
| 00763000253615 | AUGER 6061011 AUGER |
| 00763000253608 | HANDLE 6061009 RELEASE HANDLE |
| 00763000253561 | SLEEVE 6061003 EXTRACTOR SLEEVE |
| 00763000253585 | FUNNEL 6061005 INSERTER FUNNEL |
| 00763000292188 | ADAPTER 6061012 NAV TRIAL ADAPTER |
| 00763000253578 | PUSHER 6061004 INSERTER PUSHER |