N/A

Primary DI
08800043918551
Brand
N/A
Company
TDM Co., Ltd.
Model
793501-1028
Catalog number
793501-1028
Device description
MIFix Cannulated Screw 3.5 X 28mm
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
08800043918551PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800043918551088000439185518800043918551

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
08800043913082N/A3300-28083300-28082026-04-17
08800043908910N/A530-01015530-010152025-01-17
08800043908927N/A530-01020530-010202025-01-17
08809350894374N/A530-00000530-000002025-01-17
08809350894381N/A530-00005530-000052025-01-17
08809350894398N/A530-00010530-000102025-01-17
08809350898754N/A530-01000530-010002025-01-17
08809350898761N/A530-01005530-010052025-01-17
08809350898778N/A530-01010530-010102025-01-17
08809517538431N/A533-20300533-203002025-01-17
08809517538448N/A533-20301533-203012025-01-17
08809517538455N/A533-20305533-203052025-01-17
08809517538462N/A533-20310533-203102025-01-17
08809517538479N/A533-20315533-203152025-01-17
08800043909009N/A508-30015508-300152025-02-04
08800043909016N/A508-30020508-300202025-02-04
08809319845911N/A508-30000508-300002025-02-04
08809319845928N/A508-30005508-300052025-02-04
08809319845935N/A508-30010508-300102025-02-04
08809319849643N/A508-30001508-300012025-02-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810211040227Headed Screw Partially Threaded Short 3.0mm,30mm LengthPace Surgical, Inc.HWC2026-03-19
08059386744369RONDO'CITIEFFE SRLHWC2026-03-17
00888867529038Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529083Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529090Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529113Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529144Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529151Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529182Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529212Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529373Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529434Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529441Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529526Arthrex®ARTHREX, INC.HWC2026-03-16
00888867531918Arthrex®ARTHREX, INC.HWC2026-03-16
00888867531932Arthrex®ARTHREX, INC.HWC2026-03-16
00888867531949Arthrex®ARTHREX, INC.HWC2026-03-16
00888867531963Arthrex®ARTHREX, INC.HWC2026-03-16
00888867531970Arthrex®ARTHREX, INC.HWC2026-03-16
00888867531987Arthrex®ARTHREX, INC.HWC2026-03-16
00888867532007Arthrex®ARTHREX, INC.HWC2026-03-16
00888867532014Arthrex®ARTHREX, INC.HWC2026-03-16
00888867532069Arthrex®ARTHREX, INC.HWC2026-03-16
00888867532083Arthrex®ARTHREX, INC.HWC2026-03-16
00888867532137Arthrex®ARTHREX, INC.HWC2026-03-16
00888867532144Arthrex®ARTHREX, INC.HWC2026-03-16
00888867532281Arthrex®ARTHREX, INC.HWC2026-03-16
04053613298315Guide Pin SmoothGebr. Brasseler GmbH & Co. KGHWC2026-03-11
00840124525474PolyLock MidfootFUSION ORTHOPEDICS, LLCHWC2026-03-10
00840124525481PolyLock MidfootFUSION ORTHOPEDICS, LLCHWC2026-03-10