FDA.reportPublic FDA data

My3D® Personalized Pelvic Reconstruction

Primary DI
B278HD35TRQ04N0
Brand
My3D® Personalized Pelvic Reconstruction
Company
ONKOS SURGICAL, INC.
Model
HD-35TRQ-04N
Catalog number
HD-35TRQ-04N
Device description
TORQUE LIMITING ZSJ HALL HANDLE, 35IN-LBS
Published
2023-02-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212815000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212815000My3D® Personalized Pelvic ReconstructionOnkos Surgical2022-07-06LPH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B278HD35TRQ04N0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument handle, torque-limitingA hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, typically manual rotation of a bone screw or setscrew, whilst providing a torque-limiting function to ensure that the screw is not over tightened, during an orthopaedic procedure. The device is typically made of metal/synthetic material (e.g., polysulphone) and may have a T-shaped handle grip. It will normally provide an indication to the surgeon when the pre-set torque level is reached with an audible click and release of rotational traction. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
080254074
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B278AM25002200C0ELEOS™ Limb Salvage System with NanoCept® TechnologyAM-25002200-CAM-25002200-C2026-06-09
B278IMPBIMPEXSM0JTS EXTENDIBLE DISTAL FEMORAL IMPLANTimpbimp/ExSmIMPBIMP-EXSM2024-07-22
B278IMPBIMPSM0JTS EXTENDIBLE DISTAL FEMORAL IMPLANTimpbimp/SmIMPBIMP-SM2024-07-22
B278IMGENIMP0JTS EXTENDIBLE DISTAL FEMORAL IMPLANTimgenimpIMGENIMP2024-07-19
B278IMPBIMPSTD0JTS EXTENDIBLE DISTAL FEMORAL IMPLANTimpbimp/StdIMPBIMP-STD2024-07-19
B278HDSP03604N0My3D® Personalized Pelvic Reconstruction DG-SP036-04NDG-SP036-04N2023-02-22
B278IMCIRPR0JTS EXTENDIBLE DISTAL FEMORAL IMPLANTimcirprIMCIRPR2024-07-19
B278HC1112003M0ELEOS Limb Salvage System With BioGripHC-11120-03M HC-11120-03M 2021-06-30
B278HC1312003M0ELEOS Limb Salvage System With BioGripHC-13120-03M HC-13120-03M 2021-06-30
B278HC1512003M0ELEOS Limb Salvage System With BioGripHC-15120-03M HC-15120-03M 2021-06-30
B278HC1712003M0ELEOS Limb Salvage System With BioGripHC-17120-03M HC-17120-03M 2021-06-30
B278DV3500004N0My3D® Personalized Pelvic ReconstructionDV-35000-04N2025-09-22
B278DVMOD3504N0My3D® Personalized Pelvic ReconstructionDV-MOD35-04N2025-09-22
B278DVRDG3504N0My3D® Personalized Pelvic ReconstructionDV-RGD35-04N2025-09-22
B278PINS0JTS EXTENDIBLE DISTAL FEMORAL IMPLANTibnpinPINS2024-07-22
B278LS5001804M0My3D® Personalized Pelvic Reconstruction LS-50018-04M2024-03-11
B278LS5004604M0My3D® Personalized Pelvic Reconstruction LS-50046-04M2024-03-11
B278LS5002004M0My3D® Personalized Pelvic Reconstruction LS-50020-04M2024-03-08
B278LS5002204M0My3D® Personalized Pelvic Reconstruction LS-50022-04M2024-03-08
B278LS5002404M0My3D® Personalized Pelvic Reconstruction LS-50024-04M2024-03-08

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