FDA.reportPublic FDA data

CD Horizon™ ModuLeX™ Spinal System

Primary DI
00763000848583
Brand
CD Horizon™ ModuLeX™ Spinal System
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
559200095
Device description
UAS/SS 559200095 5.5 TI VOYAGER 4 PK
Published
2025-04-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWQAppliance, fixation, spinal intervertebral body

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232141000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232141000CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System (Modular Extended Tab Head)Medtronic Sofamor Danek USA, Inc.2023-08-16NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20763000848587PrimaryGS10
00763000848583Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2076300084858720763000848587
00763000848583007630008485837630008485830763000848583

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
4
DM exempt
true
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00199150071784Medtronic Reusable InstrumentsEX02260702026-05-24
00199150071791Medtronic Reusable InstrumentsEX02260802026-05-24
00199150071807Medtronic Reusable InstrumentsEX02260902026-05-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840311263042Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263059Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263066Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263073Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263080Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263097Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263103Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263110Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263127Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263134Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263141Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263158Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263165Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263172Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263189Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263196Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263202Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263219Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263226Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263233Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263240Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263257Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263264Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263271Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263288Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263295Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263301Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263318Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263325Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263332Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02