FDA.reportPublic FDA data

SDS Growing Rod

Primary DI
08720629951300
Brand
SDS Growing Rod
Company
Baat Medical Products B.V.
Model
SDS Growing Rod
Catalog number
SDS55ASB
Device description
Axial Sliding Bearing
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
08720629951300PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08720629951300087206299513008720629951300

GMDN Terms#

Term, Definition table
TermDefinition
Spinal spring-distraction system sliding bearingAn implantable metal connection component of a spring-driven spinal distraction assembly designed to link two parallel rods, allowing controlled axial movement between them to continuously lengthen the spine and correct its curvature. It is in the form of a connector with two hollow openings into which the rods are placed in parallel. It is primarily intended for children with early-onset spinal deformities such as scoliosis.

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
08720629951256SDS Growing RodSDS Growing RodSDS55ROD2026-03-30
08720629951287SDS Growing RodSDS Growing RodSDS55BUT2026-03-30
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
08720629951256SDS Growing RodBaat Medical Products B.V.PGM2026-03-30
08720629951287SDS 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