FDA.reportPublic FDA data

CD HORIZON® Spinal System

Primary DI
00643169523869
Brand
CD HORIZON® Spinal System
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
2950007
Device description
MODULE 2950007 CANNULATED TAPS
Published
2023-02-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
KWQAppliance, fixation, spinal intervertebral body
MNHOrthosis, spondylolisthesis spinal fixation
MNIOrthosis, spinal pedicle fixation
NKBThoracolumbosacral pedicle screw system
OSHPedicle screw spinal system, adolescent idiopathic scoliosis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2
OSHPedicle Screw Spinal System, Adolescent Idiopathic ScoliosisOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153442000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153442000CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with the STEALTHSTATION System, Medtronic Reusable Instruments for Use with the IPC POWEREASE System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION and IPC POWEREASE SystemsMedtronic Sofamor Danek USA, Inc.2016-02-18NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169523869PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169523869006431695238696431695238690643169523869

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.

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
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150076468Medtronic Reusable InstrumentsX46810082026-08-03
00199150076475Medtronic Reusable InstrumentsX46820082026-08-03
00199150076482Medtronic Reusable InstrumentsX46800202026-08-03
00199150076499Medtronic Reusable InstrumentsX46800212026-08-03
00199150083473Medtronic Reusable InstrumentsEX75709002026-08-03
00763000858063T2 STRATOSPHERE™ Expandable Corpectomy System4361254002026-08-01
00763000992026MSB CD HORIZON Spinal SystemX04150662026-08-02
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840493425559RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425559RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425566RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425566RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425573RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425573RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425580RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425580RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425597RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425597RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425603RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425603RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425610RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425610RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425627RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425627RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425634RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425634RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425641RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425641RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425658RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425658RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425665RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425665RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425672RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425672RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425689RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425689RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03
00840493425696RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-03
00840493425696RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-08-03