FDA.reportPublic FDA data

T2™ Spinal System

Primary DI
00613994239013
Brand
T2™ Spinal System
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
9351315
Device description
ENDCAP 9351315 13MM 15 DEGREE
Published
2015-08-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
K131888000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131888000T2 XVBR SPINAL SYSTEM, T2 ALTITUDE EXPANDABLE CORPECTOMY DEVICEMedtronic Sofamor Danek, Inc.2013-09-23MQP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00613994239013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613994239013006139942390136139942390130613994239013

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

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
00643169328716N/A30029332017-12-09
00763000891503CD HORIZON Spinal System559006195502026-09-28
00763000891527CD HORIZON Spinal System559006101502026-09-28
00763000891541CD HORIZON Spinal System559016101502026-09-28
00763000891558CD HORIZON Spinal System559016101602026-09-28
00763000891572CD HORIZON Spinal System559016175502026-09-28
00763000891589CD HORIZON Spinal System559016175602026-09-28
00763000891602CD HORIZON Spinal System559016185502026-09-28
00763000891619CD HORIZON Spinal System559016185602026-09-28
00763000891626CD HORIZON Spinal System559016195502026-09-28
00763000891633CD HORIZON Spinal System559016195602026-09-28
00763000992521INFINITY OCT SystemG36535102026-09-26
00763000992552INFINITY OCT SystemG36535162026-09-26
00643169016798Medtronic Reusable InstrumentsX06110012022-11-27
00643169016804Medtronic Reusable InstrumentsX06110022022-11-27
00673978816241Medtronic Reusable InstrumentsX06990402022-11-27
00613994423559N/AX07072142022-11-14
00613994423566N/AX07072152022-11-14
00613994423573N/AX07072162022-11-14
00613994423603N/AX07072192022-11-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10888857160460CASCADIA™ Interbody SystemVB Spine LLCMQP2018-04-16
10888857223769CASCADIA™ Interbody SystemVB Spine LLCMQP2018-02-08
10888857223776CASCADIA™ Interbody SystemVB Spine LLCMQP2018-02-08
10888857223783CASCADIA™ Interbody SystemVB Spine LLCMQP2018-02-08
10888857223790CASCADIA™ Interbody SystemVB Spine LLCMQP2018-02-08
10888857223868CASCADIA™ Interbody SystemVB Spine LLCMQP2018-02-08
10888857223875CASCADIA™ Interbody SystemVB Spine LLCMQP2018-02-08
10888857223882CASCADIA™ Interbody SystemVB Spine LLCMQP2018-02-08
10888857223899CASCADIA™ Interbody SystemVB Spine LLCMQP2018-02-08
10888857223967CASCADIA™ Interbody SystemVB Spine LLCMQP2018-02-08
10888857223974CASCADIA™ Interbody SystemVB Spine LLCMQP2018-02-08
10888857223981CASCADIA™ Interbody SystemVB Spine LLCMQP2018-02-08
10888857223998CASCADIA™ Interbody SystemVB Spine LLCMQP2018-02-08
10888857217355CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217362CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217379CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217386CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217393CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217454CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217461CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217478CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217485CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217492CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217553CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217560CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217577CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217584CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217591CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217669CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217676CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19