FDA.reportPublic FDA data

CD HORIZON® Spinal System

Primary DI
00613994682994
Brand
CD HORIZON® Spinal System
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
X0809395
Device description
SCR X0809395 LEG 5.5 MAS TI OGTHN 5.0X75
Published
2015-09-09
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
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
KWQAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
MNHOrthosis, spondylolisthesis spinal fixation
MNIORTHOSIS, SPINAL PEDICLE FIXATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K042025000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K042025000MODIFICATION TO CD HORIZON SPINAL SYSTEMMedtronic Sofamor Danek, Inc.2004-08-25KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00613994682994PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613994682994006139946829946139946829940613994682994

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length75Millimeter
Outer Diameter5Millimeter

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
00763000750282CD HORIZON® Fenestrated Screw Spinal System557510255452026-11-01
00763000750411CD HORIZON® Fenestrated Screw Spinal System557510265552026-11-01
00763000750497MSB CD HORIZON® Fenestrated Screw Spinal System557510275402026-10-31
00763000750503CD HORIZON® Fenestrated Screw Spinal System557510275452026-11-01
00763000774165CD HORIZON Spinal System557500165302026-10-31
00763000774172MSB CD HORIZON Spinal System557500165352026-10-31
00763000774189MSB CD HORIZON Spinal System557500165402026-10-31
00763000774196MSB CD HORIZON Spinal System557500165452026-10-31
00763000774202MSB CD HORIZON Spinal System557500165502026-10-31
00763000774226MSB CD HORIZON Spinal System557500175352026-10-31
00763000774240MSB CD HORIZON Spinal System557500175452026-10-31
00763000774257MSB CD HORIZON Spinal System557500175502026-10-31
00763000774301MSB CD HORIZON Spinal System557500185452026-10-31
00763000777418CD HORIZON Spinal System557500455352026-11-01
00763000777517CD HORIZON Spinal System557500465402026-11-01
00763000777524CD HORIZON Spinal System557500465452026-11-01
00763000777692MSB CD HORIZON Spinal System557500155302026-10-31
00763000777739MSB CD HORIZON Spinal System557500155502026-10-31
00824846010746Medtronic Reusable InstrumentsEX90108492026-11-01
00824846010753Medtronic Reusable InstrumentsEX90108502026-11-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000777418CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-11-01
00763000777418CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-11-01
00763000777517CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-11-01
00763000777517CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-11-01
00763000777524CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-11-01
00763000777524CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-11-01
00763000774165CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-10-31
00763000774165CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-10-31
00763000774172MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-10-31
00763000774172MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-10-31
00763000774189MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-10-31
00763000774189MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-10-31
00763000774196MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-10-31
00763000774196MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-10-31
00763000774202MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-10-31
00763000774202MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-10-31
00763000774226MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-10-31
00763000774226MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-10-31
00763000774240MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-10-31
00763000774240MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-10-31
00763000774257MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-10-31
00763000774257MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-10-31
00763000774301MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-10-31
00763000774301MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-10-31
00763000777692MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-10-31
00763000777692MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-10-31
00763000777739MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-10-31
00763000777739MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-10-31
00810017916191SABER-XA, Expandable Spacer, 37x28mm, 16mm, (18°)ELEVATION SPINE, INC.KWQ2026-10-27
00810017913763Saber-C Body (PT), 14x15x5 6 deg.ELEVATION SPINE, INC.KWQ2026-10-26