FDA.reportPublic FDA data

N/A

Primary DI
08800043936326
Brand
N/A
Company
TDM Co., Ltd.
Model
100150-1204L
Catalog number
100150-1204L
Device description
Newcolle Distal Radius Locking Plate Ver.3 Large, Lt/4H
Published
2025-01-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
HRSPlate, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241128000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241128000TDM Plate and Screw SystemTdm Co., Ltd.2024-12-05HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800043936326PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800043936326088000439363268800043936326

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation plate, non-bioabsorbableA non-bioabsorbable, non-customized, firm, implantable sheet intended to stabilize a fractured orthopaedic bone (excluding craniofacial and spinal) to treat a traumatic/pathological fracture, to fuse a joint (arthrodesis) and/or as part of an osteotomy. Typically attached to a bone of a limb, rib, sternum, or pelvis, it is designed to be fixed in place with screws, and may be used in connection with another fixation plate; it does not incorporate a sleeve or blade. Instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be included with the plate.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
557801921
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800043913099N/A3300-28093300-28092026-06-10
08800043913105N/A3300-28103300-28102026-06-10
08800043913112N/A3300-28113300-28112026-06-10
08800043913129N/A3300-28123300-28122026-06-10
08800043913136N/A3300-28133300-28132026-06-10
08800043913143N/A3300-28143300-28142026-06-10
08800043913150N/A3305-28083305-28082026-06-10
08800043913167N/A3305-28093305-28092026-06-10
08800043913174N/A3305-28103305-28102026-06-10
08800043913181N/A3305-28113305-28112026-06-10
08800043913198N/A3305-28123305-28122026-06-10
08800043913204N/A3305-28133305-28132026-06-10
08800043913211N/A3305-28143305-28142026-06-10
08800043917288N/A3300-25083300-25082026-06-10
08800043917295N/A3300-25093300-25092026-06-10
08800043917301N/A3300-25103300-25102026-06-10
08800043917318N/A3300-25113300-25112026-06-10
08800043917325N/A3300-25123300-25122026-06-10
08800043917332N/A3300-25133300-25132026-06-10
08800043917349N/A3300-25143300-25142026-06-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630894822858APTUSMedartis AGHRS2026-07-16
07630894822865APTUSMedartis AGHRS2026-07-16
07630894822872APTUSMedartis AGHRS2026-07-16
07630894822889APTUSMedartis AGHRS2026-07-16
07630894822896APTUSMedartis AGHRS2026-07-16
07630894822902APTUSMedartis AGHRS2026-07-16
07630894822919APTUSMedartis AGHRS2026-07-16
07630894822926APTUSMedartis AGHRS2026-07-16
07630894822933APTUSMedartis AGHRS2026-07-16
07630894822940APTUSMedartis AGHRS2026-07-16
07630894822957APTUSMedartis AGHRS2026-07-16
07630894822964APTUSMedartis AGHRS2026-07-16
07630894822971APTUSMedartis AGHRS2026-07-16
07630894822988APTUSMedartis AGHRS2026-07-16
07630894822995APTUSMedartis AGHRS2026-07-16
07630894823008APTUSMedartis AGHRS2026-07-16
07630894823015APTUSMedartis AGHRS2026-07-16
07630894823022APTUSMedartis AGHRS2026-07-16
07630894823039APTUSMedartis AGHRS2026-07-16
07630894823053APTUSMedartis AGHRS2026-07-16
07630894823060APTUSMedartis AGHRS2026-07-16
07630894823084APTUSMedartis AGHRS2026-07-16
07630894823091APTUSMedartis AGHRS2026-07-16
07630894823114APTUSMedartis AGHRS2026-07-16
07630894823121APTUSMedartis AGHRS2026-07-16
07630894823145APTUSMedartis AGHRS2026-07-16
07630894823152APTUSMedartis AGHRS2026-07-16
07630894823176APTUSMedartis AGHRS2026-07-16
07630894823183APTUSMedartis AGHRS2026-07-16
07630894823206APTUSMedartis AGHRS2026-07-16