FDA.reportPublic FDA data

N/A

Primary DI
08809517539797
Brand
N/A
Company
TDM Co., Ltd.
Model
203000-1018
Catalog number
203000-1018
Device description
3.0mm Cortical Screw, Star 18mm
Published
2025-01-30
Public version status
New
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
HWCScrew, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, 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
08809517539797PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809517539797088095175397978809517539797

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw (non-sliding)A small, threaded, non-bioabsorbable, implantable rod intended for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, not used in dentistry/orthodontics, craniofacial or spinal bones, and not dedicated to intramedullary fixation/arthrodesis. It is typically of cortical or cancellous design and has a drive (e.g., slot, cross, star, polygonal) at its proximal end for introduction with a screwdriver.

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
08800043912870N/A3100-25083100-25082026-06-02
08800043912887N/A3100-25093100-25092026-06-02
08800043912894N/A3100-25103100-25102026-06-02
08800043912900N/A3100-25113100-25112026-06-02
08800043912917N/A3100-25123100-25122026-06-02
08800043912924N/A3100-25133100-25132026-06-02
08800043912931N/A3100-25143100-25142026-06-02
08800043912948N/A3104-25083104-25082026-06-02
08800043912955N/A3104-25093104-25092026-06-02
08800043912962N/A3104-25103104-25102026-06-02
08800043912979N/A3104-25113104-25112026-06-02
08800043912986N/A3104-25123104-25122026-06-02
08800043912993N/A3104-25133104-25132026-06-02
08800043913006N/A3104-25143104-25142026-06-02
08800043913013N/A3108-25083108-25082026-06-02
08800043913020N/A3108-25093108-25092026-06-02
08800043913037N/A3108-25103108-25102026-06-02
08800043913044N/A3108-25113108-25112026-06-02
08800043913051N/A3108-25123108-25122026-06-02
08800043913068N/A3108-25133108-25132026-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03700569658212Xpert PFPNEWCLIP TECHNICSHWC2026-06-03
00842188131981CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188131998CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132001CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132018CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132025CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132032CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132049CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132056CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132063Tools - HCSTrimed, INC.HWC2026-06-02
00842188132070Tools - HCSTrimed, INC.HWC2026-06-02
07630894829819APTUSMedartis AGHWC2026-06-01
07630894829826APTUSMedartis AGHWC2026-06-01
07630894829833APTUSMedartis AGHWC2026-06-01
07630894829840APTUSMedartis AGHWC2026-06-01
07630894829857APTUSMedartis AGHWC2026-06-01
07630894829864APTUSMedartis AGHWC2026-06-01
07630894829871APTUSMedartis AGHWC2026-06-01
07630894829888APTUSMedartis AGHWC2026-06-01
07630894829895APTUSMedartis AGHWC2026-06-01
07630894829901APTUSMedartis AGHWC2026-06-01
07630894829918APTUSMedartis AGHWC2026-06-01
07630894829925APTUSMedartis AGHWC2026-06-01
07630894829932APTUSMedartis AGHWC2026-06-01
07630894829949APTUSMedartis AGHWC2026-06-01
07630894829956APTUSMedartis AGHWC2026-06-01
07630894829963APTUSMedartis AGHWC2026-06-01
07630894829970APTUSMedartis AGHWC2026-06-01
07630894829987APTUSMedartis AGHWC2026-06-01
07630894829994APTUSMedartis AGHWC2026-06-01