FDA.reportPublic FDA data

CD Horizon™ ModuLeX™ Spinal System

Primary DI
00763000966799
Brand
CD Horizon™ ModuLeX™ Spinal System
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
559200045
Device description
RMAS HEAD 559200045 STERILE 4.75/5.0 TI
Published
2025-03-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
KWQAppliance, fixation, spinal intervertebral body
NKBThoracolumbosacral pedicle screw system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221244000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221244000CD Horizon™ Spinal SystemMedtronic2022-05-25NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000966799PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000966799007630009667997630009667990763000966799

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
830350380
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150076161Medtronic Reusable InstrumentsX02260412026-06-05
00199150076178Medtronic Reusable InstrumentsX02260422026-06-05
00199150080304Medtronic Reusable InstrumentsX08032922026-06-05
00199150077359Medtronic Reusable InstrumentsEX02260492026-06-01
00199150077366Medtronic Reusable InstrumentsEX02260512026-06-01
00763000857844T2 STRATOSPHERE™ Expandable Corpectomy System43612552026-06-01
00763000857943T2 STRATOSPHERE™ Expandable Corpectomy System43612202026-06-01
00763000857998T2 STRATOSPHERE™ Expandable Corpectomy System43613082026-06-01
00763000881252Clydesdale™ Spinal System49860402026-05-29
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04052536163403neon3Ulrich GmbH & Co. KGKWP2026-06-09
04052536163410neon3Ulrich GmbH & Co. KGKWP2026-06-09
08800043949180N/ATDM Co., Ltd.KWQ2026-06-05
08800043965029N/ATDM Co., Ltd.KWQ2026-06-05
08800043965036N/ATDM Co., Ltd.KWQ2026-06-05
08800043965043N/ATDM Co., Ltd.KWQ2026-06-05
08800043965050N/ATDM Co., Ltd.KWQ2026-06-05
08800043965067N/ATDM Co., Ltd.KWQ2026-06-05
08800043965074N/ATDM Co., Ltd.KWQ2026-06-05
08800043965081N/ATDM Co., Ltd.KWQ2026-06-05
08800043965098N/ATDM Co., Ltd.KWQ2026-06-05
08800043965104N/ATDM Co., Ltd.KWQ2026-06-05
08800043965111N/ATDM Co., Ltd.KWQ2026-06-05
08800043965128N/ATDM Co., Ltd.KWQ2026-06-05
08800043965135N/ATDM Co., Ltd.KWQ2026-06-05
08800043965142N/ATDM Co., Ltd.KWQ2026-06-05
08800043965159N/ATDM Co., Ltd.KWQ2026-06-05
08800043965166N/ATDM Co., Ltd.KWQ2026-06-05
08800043965173N/ATDM Co., Ltd.KWQ2026-06-05
08800043965180N/ATDM Co., Ltd.KWQ2026-06-05
08800043965197N/ATDM Co., Ltd.KWQ2026-06-05
08800043965203N/ATDM Co., Ltd.KWQ2026-06-05
08800043965210N/ATDM Co., Ltd.KWQ2026-06-05
08800043965227N/ATDM Co., Ltd.KWQ2026-06-05
08800043965234N/ATDM Co., Ltd.KWQ2026-06-05
08800043965241N/ATDM Co., Ltd.KWQ2026-06-05
08800043965258N/ATDM Co., Ltd.KWQ2026-06-05
08800043965265N/ATDM Co., Ltd.KWQ2026-06-05
08800043965272N/ATDM Co., Ltd.KWQ2026-06-05
08800043965289N/ATDM Co., Ltd.KWQ2026-06-05