FDA.reportPublic FDA data

CD HORIZON® Spinal System

Primary DI
00763000408695
Brand
CD HORIZON® Spinal System
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
9010009114
Device description
ROD 9010009114 4.75MM CCM 500MM HD LINE
Published
2021-02-27
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
OSHPedicle screw spinal system, adolescent idiopathic scoliosis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OSHPedicle Screw Spinal System, Adolescent Idiopathic ScoliosisOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K091974000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091974000MODIFICATION TO CD HORIZON SPINAL SYSTEMMedtronic Sofamor Danek USA, Inc.2009-09-02NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000408695PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000408695007630004086957630004086950763000408695

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length500Millimeter
Outer Diameter4.75Millimeter

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
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10888857001435DENALI® MI Spinal SystemVB Spine LLCOSH2018-11-05
10888857001459DENALI® MI Spinal SystemVB Spine LLCOSH2018-11-05
10888857001657DENALI® MI Spinal SystemVB Spine LLCOSH2018-11-05
10888857001688DENALI® MI Spinal SystemVB Spine LLCOSH2018-11-05
10888857001695DENALI® MI Spinal SystemVB Spine LLCOSH2018-11-05
10888857001701DENALI® MI Spinal SystemVB Spine LLCOSH2018-11-05
10888857001718DENALI® MI Spinal SystemVB Spine LLCOSH2018-11-05
10888857001497DENALI® MI Spinal SystemVB Spine LLCOSH2015-09-24
10888857001527DENALI® MI Spinal SystemVB Spine LLCOSH2015-09-24
10888857001589DENALI® MI Spinal SystemVB Spine LLCOSH2015-09-24
10888857001619DENALI® MI Spinal SystemVB Spine LLCOSH2015-09-24
10888857001640DENALI® MI Spinal SystemVB Spine LLCOSH2015-09-24
10888857001725DENALI® MI Spinal SystemVB Spine LLCOSH2015-09-24
10888857001763DENALI® MI Spinal SystemVB Spine LLCOSH2015-09-24
10888857001787DENALI® MI Spinal SystemVB Spine LLCOSH2015-09-24
10888857001824DENALI® MI Spinal SystemVB Spine LLCOSH2015-09-24
10888857001848DENALI® MI Spinal SystemVB Spine LLCOSH2015-09-24
10888857001923DENALI® MI Spinal SystemVB Spine LLCOSH2015-09-24
10888857001947DENALI® MI Spinal SystemVB Spine LLCOSH2015-09-24
10888857001978DENALI® MI Spinal SystemVB Spine LLCOSH2015-09-24
10888857001992DENALI® MI Spinal SystemVB Spine LLCOSH2015-09-24
10888857002036DENALI® MI Spinal SystemVB Spine LLCOSH2015-09-24
10888857002050DENALI® MI Spinal SystemVB Spine LLCOSH2015-09-24
10888857002074DENALI® MI Spinal SystemVB Spine LLCOSH2015-09-24
10888857002098DENALI® MI Spinal SystemVB Spine LLCOSH2015-09-24
10888857002111DENALI® MI Spinal SystemVB Spine LLCOSH2015-09-24
10888857002135DENALI® MI Spinal SystemVB Spine LLCOSH2015-09-24
10888857002159DENALI® MI Spinal SystemVB Spine LLCOSH2015-09-24
10888857002173DENALI® MI Spinal SystemVB Spine LLCOSH2015-09-24