FDA.reportPublic FDA data

CD HORIZON® Spinal System

Primary DI
00613994302960
Brand
CD HORIZON® Spinal System
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
7571490
Device description
ROD 7571490 5.5MM STRAIGHT 490MM
Published
2015-07-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NQPPOSTERIOR METAL/POLYMER SPINAL SYSTEM, FUSION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NQPPosterior Metal/Polymer Spinal System, FusionOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00613994302960PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613994302960006139943029606139943029600613994302960

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
Outer Diameter5.5Millimeter

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
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150073504Medtronic Reusable InstrumentsEX12250012026-05-25
00199150071685Medtronic Reusable InstrumentsEX02261402026-05-24
00199150071692Medtronic Reusable InstrumentsEX02261502026-05-24
00199150071708Medtronic Reusable InstrumentsEX02261602026-05-24
00199150071715Medtronic Reusable InstrumentsEX02261702026-05-24
00199150071722Medtronic Reusable InstrumentsEX02261802026-05-24
00199150071739Medtronic Reusable InstrumentsEX02261902026-05-24
00199150071746Medtronic Reusable InstrumentsEX02262002026-05-24
00199150071753Medtronic Reusable InstrumentsEX02260402026-05-24
00199150071760Medtronic Reusable InstrumentsEX02260502026-05-24
00199150071777Medtronic Reusable InstrumentsEX02260602026-05-24
00199150071784Medtronic Reusable InstrumentsEX02260702026-05-24
00199150071791Medtronic Reusable InstrumentsEX02260802026-05-24
00199150071807Medtronic Reusable InstrumentsEX02260902026-05-24
00199150071814Medtronic Reusable InstrumentsEX02261002026-05-24
00199150072057Medtronic Reusable InstrumentsX65500232026-05-23
00199150072064Medtronic Reusable InstrumentsX65500242026-05-23
00199150072576Medtronic Reusable InstrumentsEX02260222026-05-23
00199150074532Medtronic Reusable InstrumentsX12250022026-05-22
00199150074549Medtronic Reusable InstrumentsX12250032026-05-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000887087CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2026-03-16
00763000887117CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2026-03-16
00763000887148CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2026-03-16
03662663109871Dynesys Dynamic Stabilization SystemHighridge Medical, LLCNQP2025-11-14
00643169281165CD HORIZON® ASTUTE™ SPINAL SYSTEMMEDTRONIC SOFAMOR DANEK, INC.NQP2024-05-18
00643169281110CD HORIZON® ASTUTE™ SPINAL SYSTEMMEDTRONIC SOFAMOR DANEK, INC.NQP2024-05-02
00763000312985CD Horizon™ Astute™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2020-08-14
00763000312992CD Horizon™ Astute™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2020-08-14
00763000313036CD Horizon™ Astute™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2020-08-14
00763000313043CD Horizon™ Astute™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2020-08-14
00763000313050CD Horizon™ Astute™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2020-08-14
00763000313081CD Horizon™ Astute™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2020-08-14
00763000313111CD Horizon™ Astute™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2020-08-14
00889024479722Dynesys®Zimmer GmbHNQP2017-07-28
00889024479791Dynesys®Zimmer GmbHNQP2017-07-28
00889024479807Dynesys®Zimmer GmbHNQP2017-07-28
00889024481176Dynesys®Zimmer GmbHNQP2017-07-28
00889024481558Dynesys®Zimmer GmbHNQP2017-07-28
00889024481565Dynesys®Zimmer GmbHNQP2017-07-28
00889024481572Dynesys®Zimmer GmbHNQP2017-07-28
00889024481589Dynesys®Zimmer GmbHNQP2017-07-28
00889024481596Dynesys®Zimmer GmbHNQP2017-07-28
00889024481602Dynesys®Zimmer GmbHNQP2017-07-28
00889024284456Zimmer® DTO®Zimmer GmbHNQP2016-08-29
00889024325340Dynesys®ZIMMER SPINE, INC.NQP2016-06-24
00889024325227Dynesys®ZIMMER SPINE, INC.NQP2016-06-23
00889024325234Dynesys®ZIMMER SPINE, INC.NQP2016-06-23
00889024325241Dynesys®ZIMMER SPINE, INC.NQP2016-06-23
00889024325258Dynesys®ZIMMER SPINE, INC.NQP2016-06-23
00889024325265Dynesys®ZIMMER SPINE, INC.NQP2016-06-23