FDA.reportPublic FDA data

CD HORIZON® Growth Rod Conversion Set

Primary DI
00643169549777
Brand
CD HORIZON® Growth Rod Conversion Set
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
7340000GR
Device description
SET SCREW 7340000GR TI BREAK-OFF S
Published
2024-12-23
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
PGMGrowing rod system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PGMGrowing Rod SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150200000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150200000CD HORIZON Growth Rod Conversion SetMedtronic Sofamor Danek USA, Incorporated2015-02-25PGM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20643169549771PrimaryGS10
00643169549777Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2064316954977120643169549771
00643169549777006431695497776431695497770643169549777

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
830350380
Device count
2
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
20763000866253CD Horizon™ ModuLeX™ FNS Screw Set559025255352024-12-29
00763000884550n/a70809182025-06-30
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
00763000750503CD HORIZON® Fenestrated Screw Spinal System557510275452026-11-01
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000874360MSB SHILLA Growth Guidance SystemMEDTRONIC SOFAMOR DANEK, INC.PGM2026-10-23
00763000874209MSB SHILLA Growth Guidance SystemMEDTRONIC SOFAMOR DANEK, INC.PGM2026-10-11
00763000873714MSB SHILLA Growth Guidance SystemMEDTRONIC SOFAMOR DANEK, INC.PGM2026-07-04
00763000875176MSB SHILLA Growth Guidance SystemMEDTRONIC SOFAMOR DANEK, INC.PGM2026-07-04
00763000874308SHILLA™ Growth Guidance SystemMEDTRONIC SOFAMOR DANEK, INC.PGM2026-05-07
00763000874315SHILLA™ Growth Guidance SystemMEDTRONIC SOFAMOR DANEK, INC.PGM2026-05-07
08720629951256SDS Growing RodBaat Medical Products B.V.PGM2026-03-30
08720629951287SDS Growing RodBaat Medical Products B.V.PGM2026-03-30
08720629951300SDS Growing RodBaat Medical Products B.V.PGM2026-03-30
08720629951324SDS Growing RodBaat Medical Products B.V.PGM2026-03-30
08720629951478SDS Growing RodBaat Medical Products B.V.PGM2026-03-30
08720629951485SDS Growing RodBaat Medical Products B.V.PGM2026-03-30
08720629951492SDS Growing RodBaat Medical Products B.V.PGM2026-03-30
08720629951508SDS Growing RodBaat Medical Products B.V.PGM2026-03-30
08720629958750SDS Growing RodBaat Medical Products B.V.PGM2026-03-30
08720629958767SDS Growing RodBaat Medical Products B.V.PGM2026-03-30
08720629958774SDS Growing RodBaat Medical Products B.V.PGM2026-03-30
08720629958828SDS Growing RodBaat Medical Products B.V.PGM2026-03-30
00763000874070SHILLA™ Growth Guidance SystemMEDTRONIC SOFAMOR DANEK, INC.PGM2026-02-21
00763000874339SHILLA™ Growth Guidance SystemMEDTRONIC SOFAMOR DANEK, INC.PGM2026-02-12
00763000874568SHILLA™ Growth Guidance SystemMEDTRONIC SOFAMOR DANEK, INC.PGM2025-11-20
00613994796158SHILLA™ Growth Guidance SystemMEDTRONIC SOFAMOR DANEK, INC.PGM2025-11-14
00613994796738SHILLA™ Growth Guidance SystemMEDTRONIC SOFAMOR DANEK, INC.PGM2025-11-14
00613994796769SHILLA™ Growth Guidance SystemMEDTRONIC SOFAMOR DANEK, INC.PGM2025-11-14
00613994796776SHILLA™ Growth Guidance SystemMEDTRONIC SOFAMOR DANEK, INC.PGM2025-11-14
00613994796783SHILLA™ Growth Guidance SystemMEDTRONIC SOFAMOR DANEK, INC.PGM2025-11-14
00613994796837SHILLA™ Growth Guidance SystemMEDTRONIC SOFAMOR DANEK, INC.PGM2025-11-14
00613994805638SHILLA™ Growth Guidance SystemMEDTRONIC SOFAMOR DANEK, INC.PGM2025-11-14
00763000874742SHILLA™ Growth Guidance SystemMEDTRONIC SOFAMOR DANEK, INC.PGM2025-10-05
00763000874827SHILLA™ Growth Guidance SystemMEDTRONIC SOFAMOR DANEK, INC.PGM2025-10-05