FDA.reportPublic FDA data

CD Horizon Spinal System

Primary DI
00885074442082
Brand
CD Horizon Spinal System
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
7043120
Device description
LEGACY ILIAC, TI, CMAS IMP TRY
Published
2022-12-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
KCTSterilization wrap containers, trays, cassettes & other accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCTSterilization Wrap Containers, Trays, Cassettes & Other AccessoriesGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143141000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143141000CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.2014-12-01NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885074442082PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885074442082008850744420828850744420820885074442082

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. 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
00199150076451Medtronic Reusable InstrumentsX36902502026-10-19
00199150080373Medtronic Reusable InstrumentsX02260452026-10-19
00199150080380Medtronic Reusable InstrumentsX02260462026-10-19
00199150080397Medtronic Reusable InstrumentsX02260472026-10-19
00199150080403Medtronic Reusable InstrumentsX02260502026-10-19
00824846003922Medtronic Reusable InstrumentsEX06260022026-10-19
00824846013082Medtronic Reusable InstrumentsX09074302026-10-19
00824846013600Medtronic Reusable InstrumentsX07260042026-10-19
00763000750053CD HORIZON® Fenestrated Screw Spinal System557510245402026-10-16
00763000750251CD HORIZON® Fenestrated Screw Spinal System557510255302026-10-16
00763000750268CD HORIZON® Fenestrated Screw Spinal System557510255352026-10-16
00763000750275CD HORIZON® Fenestrated Screw Spinal System557510255402026-10-16
00763000750374CD HORIZON® Fenestrated Screw Spinal System557510265352026-10-16
00763000750404CD HORIZON® Fenestrated Screw Spinal System557510265502026-10-16
00824846010739Medtronic Reusable InstrumentsX06260032026-10-18
00824846013495Medtronic Reusable InstrumentsEX07260062026-10-18
00763000786458CD HORIZON® Fenestrated Screw Spinal System65411012026-10-15
00643169236967n/a74806532026-10-11
00643169236974n/a74806522026-10-11
00643169236981n/a74806512026-10-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776437695MilleniumAvalign Technologies, Inc.KCT2026-10-20
00385640095174INSTRUSAFESummit Medical, Inc.KCT2026-10-20
00385640095181INSTRUSAFESummit Medical, Inc.KCT2026-10-20
00385640095198INSTRUSAFESummit Medical, Inc.KCT2026-10-20
00385640095204INSTRUSAFESummit Medical, Inc.KCT2026-10-20
G476STER16X5X1625SteriZIgn Sterilization TraySterizign Precision Technologies, LLCKCT2026-10-20
00385640095167INSTRUSAFESummit Medical, Inc.KCT2026-10-16
10886982312327NASynthes GmbHKCT2026-10-16
10886982346704VOLTSynthes GmbHKCT2026-10-16
10886982346735VOLTSynthes GmbHKCT2026-10-16
10886982363282NASynthes GmbHKCT2026-10-16
10886982363299NASynthes GmbHKCT2026-10-16
10886982363305NASynthes GmbHKCT2026-10-16
10886982363312NASynthes GmbHKCT2026-10-16
00385640095082INSTRUSAFESummit Medical, Inc.KCT2026-10-15
00385640095099INSTRUSAFESummit Medical, Inc.KCT2026-10-15
00385640095105INSTRUSAFESummit Medical, Inc.KCT2026-10-15
00385640095112INSTRUSAFESummit Medical, Inc.KCT2026-10-15
00385640095129INSTRUSAFESummit Medical, Inc.KCT2026-10-15
00385640095136INSTRUSAFESummit Medical, Inc.KCT2026-10-15
00385640095143INSTRUSAFESummit Medical, Inc.KCT2026-10-15
00385640095150INSTRUSAFESummit Medical, Inc.KCT2026-10-15
00724995239909V. MuellerSteris CorporationKCT2026-10-15
00724995239916V. MuellerSteris CorporationKCT2026-10-15
00724995239923V. MuellerSteris CorporationKCT2026-10-15
00724995239930V. MuellerSteris CorporationKCT2026-10-15
00724995239947V. MuellerSteris CorporationKCT2026-10-15
00724995240660V. MuellerSteris CorporationKCT2026-10-15
00724995240677V. MuellerSteris CorporationKCT2026-10-15
00724995240684V. MuellerSteris CorporationKCT2026-10-15