FDA.report

CD HORIZON® Spinal System

Primary DI
00763000869076
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
59329015
Device description
CADDY 59329015 HMC CONN W/SET SCREWS
Published
2026-03-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Regulatory Flags

DUNS number
830350380
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Identifiers

IdentifierTypeAgencyPackage quantityStatus
00763000869076PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
00763000869076PrimaryGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories2General Hospital880.6850NEligible

Premarket Submissions

SubmissionSupplement
K190840000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K190840000Medtronic Transportation / Sterilization CassettesMedtronic Sofamor Danek USA, Inc.2019-10-15KCT

GMDN Terms

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.

Device Sizes

No records found.

Storage And Handling

No records found.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

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00763000710194Medtronic Reusable Instruments and AccessoriesMEDTRONIC SOFAMOR DANEK, INC.KCT2026-03-22
00199150015429CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KCT2026-03-21
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00763000869106CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KCT2026-03-21
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