FDA.reportPublic FDA data

N/A

Primary DI
08800043935589
Brand
N/A
Company
TDM Co., Ltd.
Model
775001-2080
Catalog number
775001-2080
Device description
7.5mm Limited Sliding Locking Screw, Short 80mm
Published
2024-07-22
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
HWCScrew, Fixation, Bone

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231860000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231860000TDM Screw SystemTdm Co., Ltd.2024-01-18HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800043935589PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800043935589088000439355898800043935589

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw (non-sliding)A small, threaded, non-bioabsorbable, implantable rod intended to be used 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, or used in dentistry/orthodontics, craniofacial or spinal bones. It is typically of cortical or cancellous design and has a drive (e.g., a slot, or of cross, star, or polygonal shape) at its proximal end for introduction with a screwdriver. It is made of non-bioabsorbable materials (e.g., metal).

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
00841731140395ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140401ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140418ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140425ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140432ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140449ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140456ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140463ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140470ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140487ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140494ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140500ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140517ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140524ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140531ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140548ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140555ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140562ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140593ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140609ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140616ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140623ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140630ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140647ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140654ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140661ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140678ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140685ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140692ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140708ARTEMIS FUZEVILEX LLCHWC2026-07-22