FDA.reportPublic FDA data

CD HORIZON® Fenestrated Screw Set

Primary DI
00643169679078
Brand
CD HORIZON® Fenestrated Screw Set
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
55840028555T
Device description
MAS 55840028555T 5.5/6.0 FENSTRTD 8.5X55
Published
2016-04-09
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
MNIORTHOSIS, SPINAL PEDICLE FIXATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNIOrthosis, Spinal Pedicle FixationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152604000
K193011000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152604000KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetMedtronic Sofamor Danek USA, Incorporated2016-01-06PML
K193011000CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.2020-01-10NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169679078PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169679078006431696790786431696790780643169679078

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Circumference8.5Millimeter
Length55Millimeter

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
Sterilization required before use
true

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
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00840311244881Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
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00840311244928Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
00840311244935Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
00840311244942Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
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00840311245185Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
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00840311245239Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
00840311245253Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
00840311245284Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
00840311245345Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
00840311245369Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
00840311245970Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
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00840311246045Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
00840311246113Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
00840311246175Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
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00840311246298Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03