FDA.reportPublic FDA data

CD Horizon™ ModuLeX™ Spinal System

Primary DI
20763000713021
Brand
CD Horizon™ ModuLeX™ Spinal System
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
55902508545
Device description
SHANK PK 55902508545 ST MX OG 8.5X45 2PK
Published
2023-07-01
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
K223494000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223494000CD Horizon Spinal SystemMedtronic2023-01-23NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20763000713021PackageGS12In Commercial Distribution
00763000713027PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2076300071302120763000713021
00763000713027007630007130277630007130270763000713027

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, sterileAn assembly of 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. Sterile disposable devices associated with implantation may be included.

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
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
00199150081073Medtronic Reusable InstrumentsX04260042026-07-30
00199150081905Medtronic Reusable InstrumentsX04260022026-07-30
00199150083107Medtronic Reusable InstrumentsEX10040072026-07-30
00199150083879Medtronic Reusable InstrumentsX09074112026-07-30
00763000887216MSB CD HORIZON Spinal System65435352026-07-30
00721902975158GDLH® Posterior Spinal SystemX0196-1112015-08-05
00721902975189GDLH® Posterior Spinal SystemX0196-1222015-08-05
00721902975219GDLH® Posterior Spinal SystemX0196-1262015-08-05
00721902975226GDLH® Posterior Spinal SystemX0196-1282015-08-05
00721902975233GDLH® Posterior Spinal SystemX0196-1302015-08-05
00673978130316GDLH® Posterior Spinal SystemX0196-1042015-08-24
00673978130347GDLH® Posterior Spinal SystemX0196-1072015-08-24
00673978130361GDLH® Posterior Spinal SystemX0196-1092015-08-24
00673978130385GDLH® Posterior Spinal SystemX0196-1122015-08-23
00673978130392GDLH® Posterior Spinal SystemX0196-1142015-08-24
00673978130408GDLH® Posterior Spinal SystemX0196-1162015-08-24
00673978130415GDLH® Posterior Spinal SystemX0196-1182015-08-24
00673978130422GDLH® Posterior Spinal SystemX0196-1202015-08-24
00763000992316INFINITY™ Occipitocervical Upper Thoracic SystemG365PT35262026-07-24
00763000992323INFINITY™ Occipitocervical Upper Thoracic SystemG365PT35282026-07-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000887216MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-07-30
00840493425382RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28
00840493425399RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28
00840493425405RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28
00840493425412RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28
00840493425429RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28
00840493425436RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28
00840493425443RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28
00840493425450RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28
00840493425467RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28
00840493425474RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28
00840493425481RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28
00840493425498RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28
00840493425504RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28
00840493425511RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28
00840493425528RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28
00840493425535RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28
00840493425542RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28
00190376732008Segmental Plating SystemALPHATEC SPINE, INC.KWQ2026-07-27
00190376732015Segmental Plating SystemALPHATEC SPINE, INC.KWQ2026-07-27
00190376732022Segmental Plating SystemALPHATEC SPINE, INC.KWQ2026-07-27
00190376732039Segmental Plating SystemALPHATEC SPINE, INC.KWQ2026-07-27
00190376732046Segmental Plating SystemALPHATEC SPINE, INC.KWQ2026-07-27
00190376732053Segmental Plating SystemALPHATEC SPINE, INC.KWQ2026-07-27
00190376732060Segmental Plating SystemALPHATEC SPINE, INC.KWQ2026-07-27
00190376732077Segmental Plating SystemALPHATEC SPINE, INC.KWQ2026-07-27
00190376732084Segmental Plating SystemALPHATEC SPINE, INC.KWQ2026-07-27
00190376732091Segmental Plating SystemALPHATEC SPINE, INC.KWQ2026-07-27
00190376732107Segmental Plating SystemALPHATEC SPINE, INC.KWQ2026-07-27
00190376732114Segmental Plating SystemALPHATEC SPINE, INC.KWQ2026-07-27