CAPSTONE® Spinal System
GUDID 00885074076898
CASE 2980006 CAPSTONE INS TRAY 2
MEDTRONIC SOFAMOR DANEK, INC.
Instrument tray, reusable| Primary Device ID | 00885074076898 |
| NIH Device Record Key | d68bc94a-6404-466f-be87-f9fdb152442e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CAPSTONE® Spinal System |
| Version Model Number | 2980006 |
| 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 | 00885074076898 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K190840
FDA Product Code
| FSM | TRAY, SURGICAL, INSTRUMENT |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00885074076898]
Moist Heat or Steam Sterilization
[00885074076898]
Moist Heat or Steam Sterilization
[00885074076898]
Moist Heat or Steam Sterilization
[00885074076898]
Moist Heat or Steam Sterilization
[00885074076898]
Moist Heat or Steam Sterilization
[00885074076898]
Moist Heat or Steam Sterilization
[00885074076898]
Moist Heat or Steam Sterilization
[00885074076898]
Moist Heat or Steam Sterilization
[00885074076898]
Moist Heat or Steam Sterilization
[00885074076898]
Moist Heat or Steam Sterilization
[00885074076898]
Moist Heat or Steam Sterilization
[00885074076898]
Moist Heat or Steam Sterilization
[00885074076898]
Moist Heat or Steam Sterilization
[00885074076898]
Moist Heat or Steam Sterilization
[00885074076898]
Moist Heat or Steam Sterilization
[00885074076898]
Moist Heat or Steam Sterilization
[00885074076898]
Moist Heat or Steam Sterilization
[00885074076898]
Moist Heat or Steam Sterilization
[00885074076898]
Moist Heat or Steam Sterilization
[00885074076898]
Moist Heat or Steam Sterilization
[00885074076898]
Moist Heat or Steam Sterilization
[00885074076898]
Moist Heat or Steam Sterilization
[00885074076898]
Moist Heat or Steam Sterilization
[00885074076898]
Moist Heat or Steam Sterilization
[00885074076898]
Moist Heat or Steam Sterilization
[00885074076898]
Moist Heat or Steam Sterilization
[00885074076898]
Moist Heat or Steam Sterilization
[00885074076898]
Moist Heat or Steam Sterilization
[00885074076898]
Moist Heat or Steam Sterilization
[00885074076898]
Moist Heat or Steam Sterilization
[00885074076898]
Moist Heat or Steam Sterilization
[00885074076898]
Moist Heat or Steam Sterilization
[00885074076898]
Moist Heat or Steam Sterilization
[00885074076898]
Moist Heat or Steam Sterilization
[00885074076898]
Moist Heat or Steam Sterilization
[00885074076898]
Moist Heat or Steam Sterilization
[00885074076898]
Moist Heat or Steam Sterilization
[00885074076898]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-03-08 |
| Device Publish Date | 2021-02-28 |
On-Brand Devices [CAPSTONE® Spinal System]
| 00613994806222 | TRIAL 2980732 CAPSTONE 07 X 32MM |
| 00613994692146 | SPACER X0409367 CAPSTONE PEEK 6X36X14 |
| 00613994526298 | SPACER X0708291 8X22 3 DEGREE |
| 00613994526281 | SPACER X0708292 10X22 3 DEGREE |
| 00613994526274 | SPACER X0708293 12X22 3 DEGREE |
| 00613994526267 | SPACER X0708294 8X22 6 DEGREE |
| 00613994526250 | SPACER X0708295 10X22 6 DEGREE |
| 00613994526243 | SPACER X0708296 12X22 6 DEGREE |
| 00613994526236 | SPACER X0708301 8X22 9 DEGREE |
| 00613994526229 | SPACER X0708302 10X22 9 DEGREE |
| 00613994526212 | SPACER X0708303 12X22 9 DEGREE |
| 00613994526205 | SPACER X0708304 8X26 3 DEGREE |
| 00613994526199 | SPACER X0708305 10X26 3 DEGREE |
| 00613994526182 | SPACER X0708306 12X26 3 DEGREE |
| 00613994526175 | SPACER X0708311 8X26 6 DEGREE |
| 00613994526168 | SPACER X0708312 10X26 6 DEGREE |
| 00613994526151 | SPACER X0708313 12X26 6 DEGREE |
| 00613994526144 | SPACER X0708314 8X26 9 DEGREE |
| 00613994526137 | SPACER X0708315 10X26 9 DEGREE |
| 00613994526120 | SPACER X0708316 12X26 9 DEGREE |
| 00613994444202 | SPACER 2991336 CAPSTONE PEEK 13X36 |
| 00613994387400 | SPACER 2991526 CAPSTONE PEEK 15X26 |
| 00613994387394 | SPACER 2991326 CAPSTONE PEEK 13X26 |
| 00613994387387 | SPACER 2991126 CAPSTONE PEEK 11X26 |
| 00613994387370 | SPACER 2990926 CAPSTONE PEEK 09X26 |
| 00613994387363 | SPACER 2990726 CAPSTONE PEEK 07X26 |
| 00613994387356 | SPACER 2990626 CAPSTONE PEEK 06X26 |
| 00613994387332 | SPACER 2991522 CAPSTONE PEEK 15X22 |
| 00613994387325 | SPACER 2991322 CAPSTONE PEEK 13X22 |
| 00613994387318 | SPACER 2991122 CAPSTONE PEEK 11X22 |
| 00613994387301 | SPACER 2990922 CAPSTONE PEEK 09X22 |
| 00613994387295 | SPACER 2990722 CAPSTONE PEEK 07X22 |
| 00613994387288 | SPACER 2990622 CAPSTONE PEEK 06X22 |
| 00613994387264 | SPACER 2991536 CAPSTONE PEEK 15X36 |
| 00613994387240 | SPACER 2991136 CAPSTONE PEEK 11X36 |
| 00613994387233 | SPACER 2990936 CAPSTONE PEEK 09X36 |
| 00613994387226 | SPACER 2990736 CAPSTONE PEEK 07X36 |
| 00613994387196 | SPACER 2991532 CAPSTONE PEEK 15X32 |
| 00613994387189 | SPACER 2991332 CAPSTONE PEEK 13X32 |
| 00613994387172 | SPACER 2991132 CAPSTONE PEEK 11X32 |
| 00613994387165 | SPACER 2990932 CAPSTONE PEEK 09X32 |
| 00613994387158 | SPACER 2990732 CAPSTONE PEEK 07X32 |
| 00613994291042 | SPACER 2990822 CAPSTONE PEEK 08X22 |
| 00613994291035 | SPACER 2990826 CAPSTONE PEEK 08X26 |
| 00613994291028 | SPACER 2990832 CAPSTONE PEEK 08X32 |
| 00613994291011 | SPACER 2990836 CAPSTONE PEEK 08X36 |
| 00613994291004 | SPACER 2991022 CAPSTONE PEEK 10X22 |
| 00613994290991 | SPACER 2991026 CAPSTONE PEEK 10X26 |
| 00613994290984 | SPACER 2991032 CAPSTONE PEEK 10X32 |
| 00613994290977 | SPACER 2991036 CAPSTONE PEEK 10X36 |
Trademark Results [CAPSTONE]
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