Catalyft™ LS Expandable Interbody System
GUDID 00763000518356
TRAY 981990000 GENERAL INSTRUMENTS UPPER
MEDTRONIC SOFAMOR DANEK, INC.
Instrument tray, reusable| Primary Device ID | 00763000518356 |
| NIH Device Record Key | f59fd1e5-5e4a-4744-a280-40aca5ed86b8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Catalyft™ LS Expandable Interbody System |
| Version Model Number | 981990000 |
| 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 |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000518356 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K212653
FDA Product Code
| KCT | Sterilization wrap containers, trays, cassettes & other accessories |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00763000518356]
Moist Heat or Steam Sterilization
[00763000518356]
Moist Heat or Steam Sterilization
[00763000518356]
Moist Heat or Steam Sterilization
[00763000518356]
Moist Heat or Steam Sterilization
[00763000518356]
Moist Heat or Steam Sterilization
[00763000518356]
Moist Heat or Steam Sterilization
[00763000518356]
Moist Heat or Steam Sterilization
[00763000518356]
Moist Heat or Steam Sterilization
[00763000518356]
Moist Heat or Steam Sterilization
[00763000518356]
Moist Heat or Steam Sterilization
[00763000518356]
Moist Heat or Steam Sterilization
[00763000518356]
Moist Heat or Steam Sterilization
[00763000518356]
Moist Heat or Steam Sterilization
[00763000518356]
Moist Heat or Steam Sterilization
[00763000518356]
Moist Heat or Steam Sterilization
[00763000518356]
Moist Heat or Steam Sterilization
[00763000518356]
Moist Heat or Steam Sterilization
[00763000518356]
Moist Heat or Steam Sterilization
[00763000518356]
Moist Heat or Steam Sterilization
[00763000518356]
Moist Heat or Steam Sterilization
[00763000518356]
Moist Heat or Steam Sterilization
[00763000518356]
Moist Heat or Steam Sterilization
[00763000518356]
Moist Heat or Steam Sterilization
[00763000518356]
Moist Heat or Steam Sterilization
[00763000518356]
Moist Heat or Steam Sterilization
[00763000518356]
Moist Heat or Steam Sterilization
[00763000518356]
Moist Heat or Steam Sterilization
[00763000518356]
Moist Heat or Steam Sterilization
[00763000518356]
Moist Heat or Steam Sterilization
[00763000518356]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-01-10 |
| Device Publish Date | 2022-01-02 |
On-Brand Devices [Catalyft™ LS Expandable Interbody System]
| 00763000552435 | SHAFT 981000007 ANTERIOR PARA/LORD 7N |
| 00763000552428 | SHAFT 981000006 ANTERIOR PARA/LORD 6N |
| 00763000518363 | TRAY 981990001 GENERAL INSTRUMENTS LOWER |
| 00763000518356 | TRAY 981990000 GENERAL INSTRUMENTS UPPER |
| 00763000466084 | SHAFT 981000003 ANTERIOR ANT/POST |
| 00763000466077 | SHAFT 981000002 ANTERIOR PARA/LORD |
| 00763000466060 | INSERTER 981000001 STRAIGHT INSERTER |
| 00763000465995 | SCREW 981315555 DIAMOND TIP 5.5X55MM |
| 00763000465988 | SCREW 981315550 DIAMOND TIP 5.5X50MM |
| 00763000465971 | SCREW 981315545 DIAMOND TIP 5.5X45MM |
| 00763000465964 | SCREW 981315540 DIAMOND TIP 5.5X40MM |
| 00763000465957 | SCREW 981315535 DIAMOND TIP 5.5X35MM |
| 00763000465940 | SCREW 981315530 DIAMOND TIP 5.5X30MM |
| 00763000465933 | SCREW 981315525 DIAMOND TIP 5.5X25MM |
| 00763000465926 | SCREW 981315520 DIAMOND TIP 5.5X20MM |
| 00763000465919 | SPACER 981027725 10MM ANT EXPANDABLE LG |
| 00763000465902 | SPACER 981027722 6MM ANT EXPANDABLE LG |
| 00763000465896 | SPACER 981025525 10MM ANT EXPANDABLE MD |
| 00763000465889 | SPACER 981025522 6MM ANT EXPANDABLE MD |
| 00763000465872 | SPACER 981023325 10MM ANT EXPANDABLE SM |
| 00763000465865 | SPACER 981023322 6MM ANT EXPANDABLE SM |
Trademark Results [Catalyft]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CATALYFT 97054423 not registered Live/Pending |
WARSAW ORTHOPEDIC, INC. 2021-09-30 |
 CATALYFT 86950673 not registered Dead/Abandoned |
Catalyft, LLC 2016-03-23 |
 CATALYFT 86769392 5079401 Live/Registered |
CATALYFT SUCCESS SYSTEM, INC. 2015-09-25 |
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