FDA.reportPublic FDA data

T2 STRATOSPHERE™ Expandable Corpectomy System

Primary DI
00643169709454
Brand
T2 STRATOSPHERE™ Expandable Corpectomy System
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
4360120
Device description
INSERTER 4360120 20MM/25MM INSERTER
Published
2019-07-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MQPSpinal vertebral body replacement device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQPSpinal Vertebral Body Replacement DeviceOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173125000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173125000T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek2017-12-20MQP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169709454PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169709454006431697094546431697094540643169709454

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant/trial-implant holder, reusableA hand-held manual surgical instrument designed to connect to and hold an orthopaedic implant (e.g., bone screw, bone graft) or trial implant to facilitate guidance, gauging, and monitoring of the implant or trial implant during the orthopaedic surgical intervention. The instrument is typically made of high-grade stainless steel or synthetic materials and is typically constructed in the form of a long shaft with a handle at the proximal end and an implant holding/fixation mechanism at the distal end (e.g., a threaded portion or a clamp mechanism). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
830350380
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00721902298431TOWNLEY™ Transfacetpedicular Screw Fixation SystemX873-0182015-08-18
00721902298448TOWNLEY™ Transfacetpedicular Screw Fixation SystemX873-0202015-08-18
00721902298455TOWNLEY™ Transfacetpedicular Screw Fixation SystemX873-0222015-08-18
00721902298462TOWNLEY™ Transfacetpedicular Screw Fixation SystemX873-0242015-08-19
00721902298479TOWNLEY™ Transfacetpedicular Screw Fixation SystemX873-0262015-08-18
00763000704483MSB CAPSTONE CONTROL™ Spinal System40016272026-07-20
00763000879556MSB Reusable Instruments5210-10222026-07-20
00763000992439MSB INFINITY OCT SystemG365PT40262026-07-20
00763000992446MSB INFINITY OCT SystemG365PT40282026-07-20
00763000993092MSB INFINITY OCT SystemG36555352026-07-20
00199150041183N/A593250152026-07-17
00199150072323Medtronic Reusable InstrumentsX66309032026-07-19
00199150074525Medtronic Reusable InstrumentsEX01260082026-07-19
00199150076024Medtronic Reusable InstrumentsEX03260062026-07-17
00199150081875Medtronic Reusable InstrumentsX04260032026-07-19
00643169511651SOVEREIGN™ Spinal System90100020222026-07-19
00643169511675MSB SOVEREIGN™ Spinal System90100020232026-07-19
00643169511682MSB SOVEREIGN™ Spinal System90100020242026-07-19
00643169511705MSB SOVEREIGN™ Spinal System90100020302026-07-17
00643169511712MSB SOVEREIGN™ Spinal System90100020312026-07-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
18257200151271CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151288CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151295CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151325CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151349CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151356CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151363CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151370CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151387CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151394CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151424CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151431CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151448CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151455CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151462CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151479CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151493CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151509CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151523CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151530CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151547CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151561CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151578CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151585CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151592CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151608CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151615CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151622CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151639CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151646CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17