T2 Stratosphere™ Expandable Corpectomy System
T2 Stratosphere is an expandable vertebral-body replacement system used after removal of a collapsed, damaged or unstable vertebra. It combines centerpieces, optional modular end caps and…
T2 Stratosphere is an expandable vertebral-body replacement system used after removal of a collapsed, damaged or unstable vertebra. It combines centerpieces, optional modular end caps and placement instruments.
The expandable centerpiece provides the main replacement structure. End caps can be selected to accommodate the adjacent anatomy, including the listed extended end-cap configuration.
Listed Item
Endcap 436020300 Extnded 20 X 30MM 0 DEG
Spinal Construct
The system is used from T1 to L5 with supplemental thoracolumbar fixation. It supports tumor or trauma reconstruction and is generally combined with autograft or allograft as an adjunct to fusion. In specified advanced-tumor situations, it can provide limited-duration structural support where fusion is not expected within the patient’s remaining lifespan.
3manufacturers in China registered for this device type
179catalogue numbers in this listing
30510(k) clearances naming this product code
Who Else Makes It
Concentrated in Shanghai (1), Jiangsu (1), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Record
| Listed by | Medtronic Sofamor Danek, Inc., United States |
|---|---|
| FDA product code | MQP |
| Device type | Spinal Vertebral Body Replacement Device |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| 510(k) | K173125 |
| Record published | 2024-10-14 |
| Record revised | 2022-09-16 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Label carries | lot or batch number |
| Sizes | Outer diameter 13 to 25 mm; width 25 to 30 mm; length 25 to 40 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 436025A | In distribution | |
| 436020300 | In distribution | |
| 4361220 | Outer Diameter 22.0 mm | In distribution |
| 4369916 | In distribution | |
| 4360168 | In distribution | |
| 436020C | Outer Diameter 20.0 mm | In distribution |
| 436025300 | In distribution | |
| 436025B | In distribution | |
| 436125E | Width 25.0 mm | In distribution |
| 4361165 | Outer Diameter 16.0 mm | In distribution |
| 436020350 | In distribution | |
| 4369903 | In distribution | |
| 436013E | In distribution | |
| 4369002 | In distribution | |
| 436120350 | 20×35MM | In distribution |
| 4369900 | In distribution | |
| 436020355 | In distribution | |
| 4360160 | In distribution | |
| 436025305 | In distribution | |
| 4360130 | In distribution | |
| 436025400 | In distribution | |
| 4360413 | In distribution | |
| 436113A | Outer Diameter 13.0 mm | In distribution |
| 4361135 | Outer Diameter 13.0 mm | In distribution |
| 4360258 | In distribution | |
| 436025355 | In distribution | |
| 4369912 | In distribution | |
| 436020A | H = 21mm – 27mm | In distribution |
| 4361308 | In distribution | |
| 436120400 | 20×40MM | In distribution |
| 436025450 | In distribution | |
| 436125450 | 25mm x 45mm x 0DEG | In distribution |
| 4361300 | Length 30.0 mm | In distribution |
| 436125450 | In distribution | |
| 4361138 | Outer Diameter 13.0 mm | In distribution |
| 436120E | Outer Diameter 20.0 mm | In distribution |
| 436020D | H = 41mm – 66mm | In distribution |
| 4369914 | In distribution | |
| 436113C | Outer Diameter 13.0 mm | In distribution |
| 4361160 | Outer Diameter 16.0 mm | In distribution |
| 436025A | In distribution | |
| 436020300 | In distribution | |
| 436020B | In distribution | |
| 4361200 | Outer Diameter 20.0 mm | In distribution |
| 436120C | In distribution | |
| 4360300 | In distribution | |
| 436025400 | In distribution | |
| 4360220 | In distribution | |
| 4360113 | In distribution | |
| 4360168 | In distribution | |
| 4361255 | Width 25.0 mm | In distribution |
| 436120455 | 20×45MM | In distribution |
| 436113D | Outer Diameter 13.0 mm | In distribution |
| 4360135 | In distribution | |
| 436013C | In distribution | |
| 436025350 | In distribution | |
| 436120300 | 20×30MM | In distribution |
| 436025C | In distribution | |
| 4360165 | In distribution | |
| 4360135 | In distribution | |
| 436013B | In distribution | |
| 436120C | Outer Diameter 20.0 mm | In distribution |
| 436025350 | In distribution | |
| 4369922 | In distribution | |
| 436120D | Outer Diameter 20.0 mm | In distribution |
| 4360165 | In distribution | |
| 436120B | In distribution | |
| 4361165 | In distribution | |
| 436020405 | In distribution | |
| 4361220 | In distribution | |
| 436020400 | In distribution | |
| 436013C | In distribution | |
| 4369225 | In distribution | |
| 436020E | In distribution | |
| 4360221 | In distribution | |
| 4361208 | Outer Diameter 20.0 mm | In distribution |
| 4360258 | In distribution | |
| 4361308 | Length 30.0 mm | In distribution |
| 436020C | In distribution | |
| 436113B | Outer Diameter 13.0 mm | In distribution |
| 436125355 | 25mm x 35mm x 15DEG | In distribution |
| 436020450 | In distribution | |
| 436120300 | In distribution | |
| 436020D | In distribution | |
| 4360255 | In distribution | |
| 436013B | In distribution | |
| 436025D | In distribution | |
| 4360420 | In distribution | |
| 436120A | In distribution | |
| 4360228 | In distribution | |
| 4361168 | Outer Diameter 16.0 mm | In distribution |
| 436125C | Width 25.0 mm | In distribution |
| 4360225 | In distribution | |
| 4361138 | In distribution | |
| 4369917 | In distribution | |
| 4369002 | In distribution | |
| 436020350 | In distribution | |
| 436125B | In distribution | |
| 436025E | In distribution | |
| 4360138 | In distribution | |
| 4360120 | In distribution | |
| 4361168 | In distribution | |
| 4369225 | In distribution | |
| 4361205 | Outer Diameter 20.0 mm | In distribution |
| 4361225 | Outer Diameter 22.0 mm | In distribution |
| 4369904 | In distribution | |
| 4360305 | In distribution | |
| 4360208 | In distribution | |
| 4369919 | In distribution | |
| 4369915 | In distribution | |
| 4360308 | In distribution | |
| 4360205 | In distribution | |
| 436020A | In distribution | |
| 436125455 | 25mm x 45mm x 15DEG | In distribution |
| 436025C | In distribution | |
| 4369920 | In distribution | |
| 436120450 | 20×45MM | In distribution |
| 436020450 | In distribution | |
| 436025B | In distribution | |
| 4360308 | In distribution | |
| 4360225 | In distribution | |
| 436025455 | In distribution | |
| 436125A | In distribution | |
| 436125B | Length 25.0 mm | In distribution |
| 436125305 | 25mm x 30mm x 15DEG | In distribution |
| 436120A | Outer Diameter 20.0 mm | In distribution |
| 4360160 | In distribution | |
| 4361250 | Outer Diameter 25.0 mm | In distribution |
| 4360208 | In distribution | |
| 4360420 | In distribution | |
| 4360138 | In distribution | |
| 4361258 | Length 25.0 mm | In distribution |
| 4360228 | In distribution | |
| 436013A | In distribution | |
| 4360113 | In distribution | |
| 436013D | In distribution | |
| 436120D | In distribution | |
| 436013E | In distribution | |
| 436020B | Outer Diameter 20.0 mm | In distribution |
| 436125350 | 25mm x 35mm x 0DEG | In distribution |
| 436020400 | In distribution | |
| 436013D | In distribution | |
| 436025300 | In distribution | |
| 436120405 | 20×40MM | In distribution |
| 4360413 | In distribution | |
| 4361305 | Width 30.0 mm | In distribution |
| 4360305 | In distribution | |
| 4360220 | In distribution | |
| 436025450 | In distribution | |
| 4361305 | In distribution | |
| 4360120 | In distribution | |
| 436025D | In distribution | |
| 4369003 | In distribution | |
| 4361130 | Outer Diameter 13.0 mm | In distribution |
| 4369911 | In distribution | |
| 436025405 | In distribution | |
| 436125300 | 25x30MM | In distribution |
| 436120B | Outer Diameter 20.0 mm | In distribution |
| 436025E | DIA=25mm x H=63mm – 107mm | In distribution |
| 4360300 | In distribution | |
| 4360255 | In distribution | |
| 436020305 | In distribution | |
| 436125400 | 25mm x 40mm x 0DEG | In distribution |
| 4360250 | In distribution | |
| 436125D | Length 40.0 mm | In distribution |
| 436020E | In distribution | |
| 436125A | Width 25.0 mm | In distribution |
| 436120305 | 20×30MM | In distribution |
| 4360200 | In distribution | |
| 436113E | Outer Diameter 13.0 mm | In distribution |
| 4369902 | In distribution | |
| 436120355 | 20×35MM | In distribution |
| 4369918 | In distribution | |
| 4360205 | In distribution | |
| 4369003 | In distribution | |
| 4361228 | Outer Diameter 22.0 mm | In distribution |
| 4361255 | In distribution | |
| 436013A | In distribution | |
| 4369901 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CoRoent | Nuvasive, Inc. | 1,514 |
| Capri™ Corpectomy Cage System | VB Spine LLC | 1,509 |
| Aleutian® Interbody Systems | VB Spine LLC | 1,189 |
| Fortify | Globus Medical, Inc. | 866 |
| Matrixx System | Nexxt Spine LLC | 748 |
| Ascend | Alphatec Spine, Inc. | 555 |
| Zavation VBR Trial | Zavation | 548 |
| Verte-Stack® Spinal System | Medtronic Sofamor Danek, Inc. | 484 |
| Timberline® Lateral Interbody Fusion System | Biomet Spine | 470 |
| Timberline Lateral Fusion System | Biomet Spine | 459 |
| Novel | Alphatec Spine, Inc. | 447 |
| Hawkeye™ Vertebral Body Replacement (VBR) | Choice Spine, LP | 368 |
Showing 12 of 683. All products under Spinal Vertebral Body Replacement Device
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K173125 | 2017-12-20 |
| K131888 | 2013-09-23 |
| K082112 | 2008-08-27 |
| K071033 | 2007-08-14 |
| K070173 | 2007-03-14 |
| K063491 | 2007-03-05 |
| K062427 | 2006-09-12 |
| K062073 | 2006-08-14 |
| K061938 | 2006-08-09 |
| K060719 | 2006-04-14 |
| K052931 | 2005-11-16 |
| K051105 | 2005-06-09 |
| K043566 | 2005-01-07 |
| K043561 | 2004-12-29 |
| K041197 | 2004-08-09 |
| K033926 | 2004-07-07 |
| K041556 | 2004-07-01 |
| K041452 | 2004-06-24 |
| K040536 | 2004-05-05 |
| K040422 | 2004-03-19 |
| K040167 | 2004-02-18 |
| K031780 | 2003-07-30 |
| K030735 | 2003-04-18 |
| K030736 | 2003-04-02 |
| K030601 | 2003-03-25 |
| K024049 | 2003-02-26 |
| K023570 | 2002-11-19 |
| K021791 | 2002-08-26 |
| K011406 | 2001-12-27 |
| K010930 | 2001-10-24 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.