T2 STRATOSPHERE™ Expandable Corpectomy System
GUDID 00643169637320
LID 4369912 STRATOS 13MM IMPLANTS
MEDTRONIC SOFAMOR DANEK, INC.
Instrument tray| Primary Device ID | 00643169637320 |
| NIH Device Record Key | 7d6ae96a-b985-4f14-9546-42c1d5863bb4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | T2 STRATOSPHERE™ Expandable Corpectomy System |
| Version Model Number | 4369912 |
| 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 | 00643169637320 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K173125
FDA Product Code
| MQP | Spinal vertebral body replacement device |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00643169637320]
Moist Heat or Steam Sterilization
[00643169637320]
Moist Heat or Steam Sterilization
[00643169637320]
Moist Heat or Steam Sterilization
[00643169637320]
Moist Heat or Steam Sterilization
[00643169637320]
Moist Heat or Steam Sterilization
[00643169637320]
Moist Heat or Steam Sterilization
[00643169637320]
Moist Heat or Steam Sterilization
[00643169637320]
Moist Heat or Steam Sterilization
[00643169637320]
Moist Heat or Steam Sterilization
[00643169637320]
Moist Heat or Steam Sterilization
[00643169637320]
Moist Heat or Steam Sterilization
[00643169637320]
Moist Heat or Steam Sterilization
[00643169637320]
Moist Heat or Steam Sterilization
[00643169637320]
Moist Heat or Steam Sterilization
[00643169637320]
Moist Heat or Steam Sterilization
[00643169637320]
Moist Heat or Steam Sterilization
[00643169637320]
Moist Heat or Steam Sterilization
[00643169637320]
Moist Heat or Steam Sterilization
[00643169637320]
Moist Heat or Steam Sterilization
[00643169637320]
Moist Heat or Steam Sterilization
[00643169637320]
Moist Heat or Steam Sterilization
[00643169637320]
Moist Heat or Steam Sterilization
[00643169637320]
Moist Heat or Steam Sterilization
[00643169637320]
Moist Heat or Steam Sterilization
[00643169637320]
Moist Heat or Steam Sterilization
[00643169637320]
Moist Heat or Steam Sterilization
[00643169637320]
Moist Heat or Steam Sterilization
[00643169637320]
Moist Heat or Steam Sterilization
[00643169637320]
Moist Heat or Steam Sterilization
[00643169637320]
Moist Heat or Steam Sterilization
[00643169637320]
Moist Heat or Steam Sterilization
[00643169637320]
Moist Heat or Steam Sterilization
[00643169637320]
Moist Heat or Steam Sterilization
[00643169637320]
Moist Heat or Steam Sterilization
[00643169637320]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-08-09 |
| Device Publish Date | 2019-07-28 |
On-Brand Devices [T2 STRATOSPHERE™ Expandable Corpectomy System]
| 00643169663190 | CENTERPIECE 436020D 20MM D-SIZE |
| 00643169663183 | CENTERPIECE 436020C 20MM C-SIZE |
| 00643169663176 | CENTERPIECE 436020B 20MM B-SIZE |
| 00643169663169 | CENTERPIECE 436020A 20MM A-SIZE |
| 00643169611801 | MACHINE SCREW 4369003 3MM SLOTTED |
| 00763000091255 | TEMPLATE NAV4362530 25MM/30MM TEMPLATE |
| 00763000091248 | TEMPLATE NAV4362022 20MM/22MM TEMPLATE |
| 00643169611900 | TEMPLATE NAV4361316 13MM/16MM TEMPLATE |
| 00643169611894 | INSERTER NAV4360221 20MM/25MM ANGLED |
| 00643169611870 | INSERTER NAV4360120 20MM/25MM INSERTER |
| 00643169611863 | INSERTER NAV4360113 13MM INSERTER |
| 00643169611825 | TEMPLATE NAV4360030 30MM EXTENDED |
| 00763000168711 | TRAY 4369922 STRATOSPHERE NAV INSTRMENTS |
| 00643169637405 | LID 4369920 20-25MM CENTERPIECE MODULE |
| 00643169638518 | TRAY 4369903 LATERAL TEMPLATES-IMPLANTS |
| 00643169637399 | MODULE 4369919 20-25MM CENTERPIECE |
| 00643169663145 | CENTERPIECE 436013D 13MM D-SIZE |
| 00643169709461 | INSERTER 4360221 20MM/25MM ANGLED |
| 00643169709454 | INSERTER 4360120 20MM/25MM INSERTER |
| 00643169709447 | INSERTER 4360113 13MM INSERTER |
| 00643169611795 | MACHINE SCREW 4369002 2MM SLOTTED |
| 00643169709560 | ENDCAP 436025455 EXTND 25 X 45MM 15 DEG |
| 00643169709553 | ENDCAP 436025405 EXTND 25 X 40MM 15 DEG |
| 00643169709546 | ENDCAP 436025355 EXTND 25 X 35MM 15 DEG |
| 00643169709539 | ENDCAP 436025305 EXTND 25 X 30MM 15 DEG |
| 00643169709508 | ENDCAP 436020355 EXTND 20 X 35MM 15 DEG |
| 00643169709492 | ENDCAP 436020305 EXTND 20 X 30MM 15 DEG |
| 00643169663251 | CENTERPIECE 436025E 25MM E-SIZE |
| 00643169663244 | CENTERPIECE 436025D 25MM D-SIZE |
| 00643169663237 | CENTERPIECE 436025C 25MM C-SIZE |
| 00643169663220 | CENTERPIECE 436025B 25MM B-SIZE |
| 00643169663213 | CENTERPIECE 436025A 25MM A-SIZE |
| 00643169663206 | CENTERPIECE 436020E 20MM E-SIZE |
| 00643169663152 | CENTERPIECE 436013E 13MM E-SIZE |
| 00643169663138 | CENTERPIECE 436013C 13MM C-SIZE |
| 00643169663121 | CENTERPIECE 436013B 13MM B-SIZE |
| 00643169663114 | CENTERPIECE 436013A 13MM A-SIZE |
| 00643169651104 | ENDCAP 436025450 EXTNDED 25 X 45MM 0 DEG |
| 00643169651098 | ENDCAP 436025400 EXTNDED 25 X 40MM 0 DEG |
| 00643169651081 | ENDCAP 436025350 EXTNDED 25 X 35MM 0 DEG |
| 00643169651074 | ENDCAP 436025300 EXTNDED 25 X 30MM 0 DEG |
| 00643169651067 | ENDCAP 436020450 EXTNDED 20 X 45MM 0 DEG |
| 00643169651050 | ENDCAP 436020400 EXTNDED 20 X 40MM 0 DEG |
| 00643169651043 | ENDCAP 436020350 EXTNDED 20 X 35MM 0 DEG |
| 00643169651036 | ENDCAP 436020300 EXTNDED 20 X 30MM 0 DEG |
| 00643169651029 | ENDCAP 4360308 30MM 8 DEGREE |
| 00643169651012 | ENDCAP 4360305 30MM 15 DEGREE |
| 00643169651005 | ENDCAP 4360300 30MM 0 DEGREE |
| 00643169650992 | ENDCAP 4360258 25MM 8 DEGREE |
| 00643169650985 | ENDCAP 4360255 25MM 15 DEGREE |
Trademark Results [T2 STRATOSPHERE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 T2 STRATOSPHERE 86817545 5546279 Live/Registered |
Warsaw Orthopedic, Inc. 2015-11-12 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.