FDA.reportPublic FDA data

CD HORIZON® Spinal System

Primary DI
00721902500060
Brand
CD HORIZON® Spinal System
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
XIB0402-006
Device description
SPECIAL 8 X 11 TCR
Published
2015-07-30
Public version status
Update
Distribution status
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
JDKProsthesis, hip, cement restrictor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDKProsthesis, Hip, Cement RestrictorGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K003718000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K003718000TITANIUM CEMENT RESTRICTOR (TCR)Medtronic Sofamor Danek, Inc.2001-02-14JDK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00721902500060PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00721902500060007219025000607219025000600721902500060

GMDN Terms#

Term, Definition table
TermDefinition
Metallic 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 metal [e.g., titanium (Ti)] 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
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
00643169588219Medtronic Resuable InstrumentsX08108352022-11-14
00643169860940Medtronic Resuable InstrumentsX07160322022-11-14
00643169860957Medtronic Resuable InstrumentsX07160332022-11-14
00613994107169Medtronic Reusable InstrumentsX08050732022-10-07
00613994230676Medtronic Reusable InstrumentsX07061412022-10-07
00613994404510Medtronic Reusable InstrumentsX07061942022-10-07
00613994507129Medtronic Reusable InstrumentsX08081362022-10-07
00613994507150Medtronic Reusable InstrumentsX08081392022-10-07
00613994507174Medtronic Reusable InstrumentsX08081412022-10-07
00613994838797Medtronic Reusable InstrumentsX06102712022-10-07
00613994838803Medtronic Reusable InstrumentsX06102702022-10-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08031497002842MectaCem BonePrepTECRES SPAJDK2022-11-17
07630345710963MectaPlug PE IIMedacta International SAJDK2021-04-16
07630345710970MectaPlug PE IIMedacta International SAJDK2021-04-16
07630345710987MectaPlug PE IIMedacta International SAJDK2021-04-16
07630345710994MectaPlug PE IIMedacta International SAJDK2021-04-16
07630345711007MectaPlug PE IIMedacta International SAJDK2021-04-16
08053369431048Emotec srlEMOTEC SRLJDK2021-02-03
00840019908757ShurFit CRT Peek CagePRECISION SPINE, INC.JDK2019-04-12
00840019908764ShurFit CRT Peek CagePRECISION SPINE, INC.JDK2019-04-12
00840019908771ShurFit CRT Peek CagePRECISION SPINE, INC.JDK2019-04-12
00840019908788ShurFit CRT Peek CagePRECISION SPINE, INC.JDK2019-04-12
00840019908795ShurFit CRT Peek CagePRECISION SPINE, INC.JDK2019-04-12
00840019908801ShurFit CRT Peek CagePRECISION SPINE, INC.JDK2019-04-12
00840019908818ShurFit CRT Peek CagePRECISION SPINE, INC.JDK2019-04-12
00840019908825ShurFit CRT Peek CagePRECISION SPINE, INC.JDK2019-04-12
00840019908832ShurFit CRT Peek CagePRECISION SPINE, INC.JDK2019-04-12
00840019908849ShurFit CRT Peek CagePRECISION SPINE, INC.JDK2019-04-12
00840019908856ShurFit CRT Peek CagePRECISION SPINE, INC.JDK2019-04-12
00840019908863ShurFit CRT Peek CagePRECISION SPINE, INC.JDK2019-04-12
00840019908870ShurFit CRT Peek CagePRECISION SPINE, INC.JDK2019-04-12
00840019908887ShurFit CRT Peek CagePRECISION SPINE, INC.JDK2019-04-12
00840019908894ShurFit CRT Peek CagePRECISION SPINE, INC.JDK2019-04-12
00840019908900ShurFit CRT Peek CagePRECISION SPINE, INC.JDK2019-04-12
00815362022122ShurFit ACIF Titanium PRECISION SPINE, INC.JDK2019-03-28
00840019929233ShurFit ACIF Titanium PRECISION SPINE, INC.JDK2019-03-28
00840019929257ShurFit ACIF Titanium PRECISION SPINE, INC.JDK2019-03-28
00840019929240ShurFit ACIF Titanium PRECISION SPINE, INC.JDK2019-03-27
00840019929264ShurFit ACIF Titanium PRECISION SPINE, INC.JDK2019-03-27
00840019929271ShurFit ACIF Titanium PRECISION SPINE, INC.JDK2019-03-27
08031497001401Cement RestrictorTECRES SPAJDK2015-10-12