FDA.reportPublic FDA data

SHILLA™ Growth Guidance System

Primary DI
00613994805638
Brand
SHILLA™ Growth Guidance System
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
7673425
Device description
SCREW 7673425 4.5 SHILLA FAS 4.5X25
Published
2025-11-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
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
K140750000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140750000SHILLA GROWTH GUIDANCE SYSTEMMedtronic Sofamor Danek USA, Inc.2014-07-17PGM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00613994805638PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613994805638006139948056386139948056380613994805638

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system rodAn implantable component of a bone-screw internal spinal fixation system in the form of a thin cylinder intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. This component is designed as a longitudinal (intervertebral) connecting element passing through the system’s implantable screw heads or hooks. It is available in various forms (e.g., straight, curved, rigid, flexible, with varying diameters); flexible types may allow small movements of the spine.

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
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
00763000874742SHILLA™ Growth Guidance SystemMEDTRONIC SOFAMOR DANEK, INC.PGM2025-10-05
00763000874827SHILLA™ Growth Guidance SystemMEDTRONIC SOFAMOR DANEK, INC.PGM2025-10-05
00763000875213SHILLA™ Growth Guidance SystemMEDTRONIC SOFAMOR DANEK, INC.PGM2025-10-05
00763000875237SHILLA™ Growth Guidance SystemMEDTRONIC SOFAMOR DANEK, INC.PGM2025-10-05
00763000874445SHILLA™ Growth Guidance SystemMEDTRONIC SOFAMOR DANEK, INC.PGM2025-10-04
00763000875183SHILLA™ Growth Guidance SystemMEDTRONIC SOFAMOR DANEK, INC.PGM2025-10-03
00763000875282SHILLA™ Growth Guidance SystemMEDTRONIC SOFAMOR DANEK, INC.PGM2025-09-27