FDA.reportPublic FDA data

CD HORIZON® Fenestrated Screw Spinal System

Primary DI
00763000750503
Brand
CD HORIZON® Fenestrated Screw Spinal System
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
55751027545
Device description
FNS SAS 55751027545 STER CCM 7.5 X 45
Published
2026-11-01
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
NDNCEMENT, BONE, VERTEBROPLASTY
NKBThoracolumbosacral pedicle screw system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDNCement, Bone, VertebroplastyOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201362000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201362000CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone CementMedtronic2020-08-19PML

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000750503PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000750503007630007505037630007505030763000750503

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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00763000750282CD HORIZON® Fenestrated Screw Spinal System557510255452026-11-01
00763000750411CD HORIZON® Fenestrated Screw Spinal System557510265552026-11-01
00763000750497MSB CD HORIZON® Fenestrated Screw Spinal System557510275402026-10-31
00763000774165CD HORIZON Spinal System557500165302026-10-31
00763000774172MSB CD HORIZON Spinal System557500165352026-10-31
00763000774189MSB CD HORIZON Spinal System557500165402026-10-31
00763000774196MSB CD HORIZON Spinal System557500165452026-10-31
00763000774202MSB CD HORIZON Spinal System557500165502026-10-31
00763000774226MSB CD HORIZON Spinal System557500175352026-10-31
00763000774240MSB CD HORIZON Spinal System557500175452026-10-31
00763000774257MSB CD HORIZON Spinal System557500175502026-10-31
00763000774301MSB CD HORIZON Spinal System557500185452026-10-31
00763000777418CD HORIZON Spinal System557500455352026-11-01
00763000777517CD HORIZON Spinal System557500465402026-11-01
00763000777524CD HORIZON Spinal System557500465452026-11-01
00763000777692MSB CD HORIZON Spinal System557500155302026-10-31
00763000777739MSB CD HORIZON Spinal System557500155502026-10-31
00824846010746Medtronic Reusable InstrumentsEX90108492026-11-01
00824846010753Medtronic Reusable InstrumentsEX90108502026-11-01
00199150081073Medtronic Reusable InstrumentsX04260042026-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00197157123734ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123741ZAVATION SCREWZavation LLCNKB2026-11-02
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00197157123765ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123772ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123789ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123796ZAVATION SCREWZavation LLCNKB2026-11-02
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00197157123819ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123826ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123833ZAVATION SCREWZavation LLCNKB2026-11-02
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00197157123918ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123925ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123932ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123949ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123956ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123963ZAVATION SCREWZavation LLCNKB2026-11-02