T2 STRATOSPHERE™ Expandable Corpectomy System
GUDID 00763000091255
TEMPLATE NAV4362530 25MM/30MM TEMPLATE
MEDTRONIC SOFAMOR DANEK, INC.
Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable| Primary Device ID | 00763000091255 |
| NIH Device Record Key | 7d77a577-eb84-4433-97cc-f647e5bdaf7c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | T2 STRATOSPHERE™ Expandable Corpectomy System |
| Version Model Number | NAV4362530 |
| 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
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000091255 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K191039
FDA Product Code
| OLO | Orthopedic stereotaxic instrument |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00763000091255]
Moist Heat or Steam Sterilization
[00763000091255]
Moist Heat or Steam Sterilization
[00763000091255]
Moist Heat or Steam Sterilization
[00763000091255]
Moist Heat or Steam Sterilization
[00763000091255]
Moist Heat or Steam Sterilization
[00763000091255]
Moist Heat or Steam Sterilization
[00763000091255]
Moist Heat or Steam Sterilization
[00763000091255]
Moist Heat or Steam Sterilization
[00763000091255]
Moist Heat or Steam Sterilization
[00763000091255]
Moist Heat or Steam Sterilization
[00763000091255]
Moist Heat or Steam Sterilization
[00763000091255]
Moist Heat or Steam Sterilization
[00763000091255]
Moist Heat or Steam Sterilization
[00763000091255]
Moist Heat or Steam Sterilization
[00763000091255]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-09-26 |
| Device Publish Date | 2019-09-18 |
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.