FDA.reportPublic FDA data

CD HORIZON Spinal System

Primary DI
00763000891480
Brand
CD HORIZON Spinal System
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
55900618550
Device description
SHANK 55900618550 ILIAC CANN 8.5X50MM
Published
2026-09-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
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
K233951000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233951000CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.2024-03-27NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000891480PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000891480007630008914807630008914800763000891480

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
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
00643169524699Reusable Instruments21511302026-09-20
00763000891428CD HORIZON Spinal System559006001602026-09-20
00763000992538INFINITY OCT SystemG36535122026-09-20
00763000992545INFINITY OCT SystemG36535142026-09-20
00763000992569INFINITY OCT SystemG36535182026-09-20
00824846008477Medtronic Reusable InstrumentsEX29420202026-09-19
00763000703929MSB CAPSTONE CONTROL™ Spinal System39914222026-08-27
00763000703936MSB CAPSTONE CONTROL™ Spinal System39914272026-08-27
00763000703950MSB CAPSTONE CONTROL™ Spinal System39915222026-08-27
00763000703967MSB CAPSTONE CONTROL™ Spinal System39915272026-08-27
00763000703981MSB CAPSTONE CONTROL™ Spinal System39916222026-08-27
00763000703998MSB CAPSTONE CONTROL™ Spinal System39916272026-08-27
00763000704001MSB CAPSTONE CONTROL™ Spinal System39916322026-08-27
00763000704018MSB CAPSTONE CONTROL™ Spinal System39917222026-08-27
00763000704025MSB CAPSTONE CONTROL™ Spinal System39917272026-08-27
00763000704032MSB CAPSTONE CONTROL™ Spinal System39917322026-08-27
00763000704049MSB CAPSTONE CONTROL™ Spinal System39913322026-08-27
00763000704063MSB CAPSTONE CONTROL™ Spinal System39908272026-08-27
00763000704070MSB CAPSTONE CONTROL™ Spinal System39909222026-08-27
00763000704100MSB CAPSTONE CONTROL™ Spinal System39910272026-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000891428CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-09-20
00763000891428CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-09-20
00763000891428CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2026-09-20
00197157116712ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116729ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116736ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116743ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116750ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116767ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116774ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116781ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116798ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116804ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116811ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116828ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116835ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116842ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116859ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116866ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116873ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116880ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116897ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116903ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116910ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116927ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116934ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116941ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116958ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116965ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116972ZAVATION SCREWZavation LLCNKB2026-09-18