N/A

Primary DI
08800043918667
Brand
N/A
Company
TDM Co., Ltd.
Model
793501-1050
Catalog number
793501-1050
Device description
MIFix Cannulated Screw 3.5 X 50mm
Published
2024-07-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
08800043918667PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800043918667088000439186678800043918667

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
08800043901454N/A727-25010727-250102025-02-05
08800043901461N/A727-25012727-250122025-02-05
08800043901478N/A727-25014727-250142025-02-05
08800043901485N/A727-25016727-250162025-02-05
08800043901492N/A727-25020727-250202025-02-05
08800043901508N/A727-25022727-250222025-02-05
08800043901515N/A727-25026727-250262025-02-05

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