T2 STRATOSPHERE™ Expandable Corpectomy System

GUDID 00643169637320

LID 4369912 STRATOS 13MM IMPLANTS

MEDTRONIC SOFAMOR DANEK, INC.

Instrument tray
Primary Device ID00643169637320
NIH Device Record Key7d6ae96a-b985-4f14-9546-42c1d5863bb4
Commercial Distribution StatusIn Commercial Distribution
Brand NameT2 STRATOSPHERE™ Expandable Corpectomy System
Version Model Number4369912
Company DUNS830350380
Company NameMEDTRONIC SOFAMOR DANEK, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169637320 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQPSpinal vertebral body replacement device

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[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 StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-08-09
Device Publish Date2019-07-28

On-Brand Devices [T2 STRATOSPHERE™ Expandable Corpectomy System]

00643169663190CENTERPIECE 436020D 20MM D-SIZE
00643169663183CENTERPIECE 436020C 20MM C-SIZE
00643169663176CENTERPIECE 436020B 20MM B-SIZE
00643169663169CENTERPIECE 436020A 20MM A-SIZE
00643169611801MACHINE SCREW 4369003 3MM SLOTTED
00763000091255TEMPLATE NAV4362530 25MM/30MM TEMPLATE
00763000091248TEMPLATE NAV4362022 20MM/22MM TEMPLATE
00643169611900TEMPLATE NAV4361316 13MM/16MM TEMPLATE
00643169611894INSERTER NAV4360221 20MM/25MM ANGLED
00643169611870INSERTER NAV4360120 20MM/25MM INSERTER
00643169611863INSERTER NAV4360113 13MM INSERTER
00643169611825TEMPLATE NAV4360030 30MM EXTENDED
00763000168711TRAY 4369922 STRATOSPHERE NAV INSTRMENTS
00643169637405LID 4369920 20-25MM CENTERPIECE MODULE
00643169638518TRAY 4369903 LATERAL TEMPLATES-IMPLANTS
00643169637399MODULE 4369919 20-25MM CENTERPIECE
00643169663145CENTERPIECE 436013D 13MM D-SIZE
00643169709461INSERTER 4360221 20MM/25MM ANGLED
00643169709454INSERTER 4360120 20MM/25MM INSERTER
00643169709447INSERTER 4360113 13MM INSERTER
00643169611795MACHINE SCREW 4369002 2MM SLOTTED
00643169709560ENDCAP 436025455 EXTND 25 X 45MM 15 DEG
00643169709553ENDCAP 436025405 EXTND 25 X 40MM 15 DEG
00643169709546ENDCAP 436025355 EXTND 25 X 35MM 15 DEG
00643169709539ENDCAP 436025305 EXTND 25 X 30MM 15 DEG
00643169709508ENDCAP 436020355 EXTND 20 X 35MM 15 DEG
00643169709492ENDCAP 436020305 EXTND 20 X 30MM 15 DEG
00643169663251CENTERPIECE 436025E 25MM E-SIZE
00643169663244CENTERPIECE 436025D 25MM D-SIZE
00643169663237CENTERPIECE 436025C 25MM C-SIZE
00643169663220CENTERPIECE 436025B 25MM B-SIZE
00643169663213CENTERPIECE 436025A 25MM A-SIZE
00643169663206CENTERPIECE 436020E 20MM E-SIZE
00643169663152CENTERPIECE 436013E 13MM E-SIZE
00643169663138CENTERPIECE 436013C 13MM C-SIZE
00643169663121CENTERPIECE 436013B 13MM B-SIZE
00643169663114CENTERPIECE 436013A 13MM A-SIZE
00643169651104ENDCAP 436025450 EXTNDED 25 X 45MM 0 DEG
00643169651098ENDCAP 436025400 EXTNDED 25 X 40MM 0 DEG
00643169651081ENDCAP 436025350 EXTNDED 25 X 35MM 0 DEG
00643169651074ENDCAP 436025300 EXTNDED 25 X 30MM 0 DEG
00643169651067ENDCAP 436020450 EXTNDED 20 X 45MM 0 DEG
00643169651050ENDCAP 436020400 EXTNDED 20 X 40MM 0 DEG
00643169651043ENDCAP 436020350 EXTNDED 20 X 35MM 0 DEG
00643169651036ENDCAP 436020300 EXTNDED 20 X 30MM 0 DEG
00643169651029ENDCAP 4360308 30MM 8 DEGREE
00643169651012ENDCAP 4360305 30MM 15 DEGREE
00643169651005ENDCAP 4360300 30MM 0 DEGREE
00643169650992ENDCAP 4360258 25MM 8 DEGREE
00643169650985ENDCAP 4360255 25MM 15 DEGREE

Trademark Results [T2 STRATOSPHERE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
T2 STRATOSPHERE
T2 STRATOSPHERE
86817545 5546279 Live/Registered
Warsaw Orthopedic, Inc.
2015-11-12

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