FDA.reportPublic FDA data

CD HORIZON® Spinal System

Primary DI
00763000256005
Brand
CD HORIZON® Spinal System
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
55900005545
Device description
SHANK 55900005545 OSTEOGRIP 5.5 X 45 NS
Published
2020-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K201407000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201407000CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.2020-09-10NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000256005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000256005007630002560057630002560050763000256005

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.

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
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150076451Medtronic Reusable InstrumentsX36902502026-10-19
00199150080373Medtronic Reusable InstrumentsX02260452026-10-19
00199150080380Medtronic Reusable InstrumentsX02260462026-10-19
00199150080397Medtronic Reusable InstrumentsX02260472026-10-19
00199150080403Medtronic Reusable InstrumentsX02260502026-10-19
00824846003922Medtronic Reusable InstrumentsEX06260022026-10-19
00824846013082Medtronic Reusable InstrumentsX09074302026-10-19
00824846013600Medtronic Reusable InstrumentsX07260042026-10-19
00763000750053CD HORIZON® Fenestrated Screw Spinal System557510245402026-10-16
00763000750251CD HORIZON® Fenestrated Screw Spinal System557510255302026-10-16
00763000750268CD HORIZON® Fenestrated Screw Spinal System557510255352026-10-16
00763000750275CD HORIZON® Fenestrated Screw Spinal System557510255402026-10-16
00763000750374CD HORIZON® Fenestrated Screw Spinal System557510265352026-10-16
00763000750404CD HORIZON® Fenestrated Screw Spinal System557510265502026-10-16
00824846010739Medtronic Reusable InstrumentsX06260032026-10-18
00824846013495Medtronic Reusable InstrumentsEX07260062026-10-18
00763000786458CD HORIZON® Fenestrated Screw Spinal System65411012026-10-15
00643169236967n/a74806532026-10-11
00643169236974n/a74806522026-10-11
00643169236981n/a74806512026-10-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840466901011PrimusSPINAL ELEMENTS, INC.KWP2026-10-22
00840466901011PrimusSPINAL ELEMENTS, INC.NKB2026-10-22
00840466901011PrimusSPINAL ELEMENTS, INC.KWQ2026-10-22
00840606168472SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-10-22
00840606168502SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-10-22
00840606174855PrimusSPINAL ELEMENTS, INC.NKB2026-10-22
00840606175142PrimusSPINAL ELEMENTS, INC.NKB2026-10-22
00840606175203PrimusSPINAL ELEMENTS, INC.NKB2026-10-22
00840606185868PrimusSPINAL ELEMENTS, INC.NKB2026-10-22
03701313009823KHEIRONS.M.A.I.ONKB2026-10-22
03701313009830KHEIRONS.M.A.I.ONKB2026-10-22
03701313009854KHEIRONS.M.A.I.ONKB2026-10-22
03701313009878KHEIRONS.M.A.I.ONKB2026-10-22
03701313009885KHEIRONS.M.A.I.ONKB2026-10-22
03701313009892KHEIRONS.M.A.I.ONKB2026-10-22
03701313009908KHEIRONS.M.A.I.ONKB2026-10-22
00197157123611ZAVATION SCREWZavation LLCNKB2026-10-21
00197157123628ZAVATION SCREWZavation LLCNKB2026-10-21
00197157123635ZAVATION SCREWZavation LLCNKB2026-10-21
00197157123642ZAVATION SCREWZavation LLCNKB2026-10-21
00197157123659ZAVATION SCREWZavation LLCNKB2026-10-21
00197157123666ZAVATION SCREWZavation LLCNKB2026-10-21
00197157122874ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122881ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122898ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122904ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122911ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122928ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122935ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122942ZAVATION SCREWZavation LLCNKB2026-10-20