T2 Stratosphere™ Expandable Corpectomy System

Endcap 4361135 13MM 15 Degree Sterile

Registry build 21.09.26
1manufacturer
5catalogue numbers in this listing

Who Else Makes It

Registered in Shandong. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code PLR
Manufacturer City Province Registered as Device types
Shandong Weigao Orthopaedic Device Co., Ltd. Weihai Shandong Contract manufacturer 42

Record

Regulatory record for T2 Stratosphere™ Expandable Corpectomy System
Listed by Medtronic Sofamor Danek, Inc., United States
FDA product code PLR
Device type Spinal Vertebral Body Replacement Device – Cervical
Device class Class 2
Regulation 21 CFR 888.3060
510(k) K183510
Record published 2025-10-04

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Single use Yes
Prescription Prescription only
Label carries lot or batch number

Catalogue Numbers

Catalogue numbers for T2 Stratosphere™ Expandable Corpectomy System
Catalogue number Size Status
4361160 In distribution
4361300 In distribution
4361135 In distribution
4361228 In distribution
4361205 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Alta Astura Medical 290
Ascend Alphatec Spine, Inc. 267
Matrixx System Nexxt Spine LLC 88
Colosseum Globus Medical, Inc. 87
Palo Alto Corpectomy Cage System VB Spine LLC 56
C-VBR VB Spine LLC 53
Trabis® Coligne AG 34
X-Core Nuvasive, Inc. 31
CarboClear Cervical VBR System CarboFix Orthopedics, Ltd. 31
Capri™ Corpectomy Cage System VB Spine LLC 25
Zavation Zavation 25
Verteloc Spinal System Signature Orthopaedics PTY Limited 17

Showing 12 of 31. All products under Spinal Vertebral Body Replacement Device – Cervical

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer