FDA.reportPublic FDA data

SDS Growing Rod

Primary DI
08720629951256
Brand
SDS Growing Rod
Company
Baat Medical Products B.V.
Model
SDS Growing Rod
Catalog number
SDS55ROD
Device description
CoCr rod 5.5mm x 500mm
Published
2026-03-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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
K251961000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251961000SDS Growing RodBAAT Medical Products B.V.2026-01-15PGM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08720629951256PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08720629951256087206299512568720629951256

GMDN Terms#

Term, Definition table
TermDefinition
Spinal spring-distraction system rodAn implantable metallic rod designed to be placed alongside the spinal column to enable curvature correction and lengthening in children with early onset spinal deformities (e.g., scoliosis). It is a component of an implant assembly that uses two long rods, two small anchor rods, springs, and sliding bearings, whereby the spring-based distraction force drives axial displacement of one long rod with respect to the other to achieve continuous spinal correction and lengthening, without the need for invasive post-implantation interventions. The rods are fixed to the vertebrae in a parallel configuration with pedicle bone screws. The rod does not feature a ratchet-based mechanism.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00The products shall be stored and handled with care. The primary and secondary packaging shall remain intact at all times. The products shall be stored and handled in an environment that is: • dry an

Regulatory Flags#

DUNS number
413205480
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08720629951287SDS Growing RodSDS Growing RodSDS55BUT2026-03-30
08720629951300SDS Growing RodSDS Growing RodSDS55ASB2026-03-30
08720629951324SDS Growing RodSDS Growing RodSDS55PSB2026-03-30
08720629951478SDS Growing RodSDS Growing RodSDSLOCK2026-03-30
08720629951485SDS Growing RodSDS Growing RodSDSCOMPR2026-03-30
08720629958750SDS Growing RodSDS Growing RodSDS55CCL2026-03-30
08720629958767SDS Growing RodSDS Growing RodSDS55S1002026-03-30
08720629958828SDS Growing RodSDS Growing RodSDSTHAN92026-03-30
08720629959573SINEFIXPunch600072026-04-01
08721515510151SINEFIXSINEFIX300012026-04-01
08720629951492SDS Growing RodSDS Growing RodSDSDRIVER2026-03-30
08720629951508SDS Growing RodSDS Growing RodSDSTRAY2026-03-30
08720629958774SDS Growing RodSDS Growing RodSDSFORC2026-03-30
08720629950464SINEFIXSINEFIX300012023-04-11
08720629950532SINEFIXRepusher400072023-04-11
08720629950549SINEFIXTray400082023-04-11
08720629959177SINEFIXSINEFIX Easy Grip600022025-07-03
08720246781960Kleiner KG2 systemKG2 Static Parallel 9x24x07x0° 02-911072022-12-14
08720246781977Kleiner KG2 systemKG2 Static Parallel 9x24x08x0°02-911082022-12-14
08720246781984Kleiner KG2 systemKG2 Static Parallel 9x24x09x0°02-911092022-12-14

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
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
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