FDA.report

N/A

Primary DI
08800043918360
Brand
N/A
Company
TDM Co., Ltd.
Model
793001-1050
Catalog number
793001-1050
Device description
MIFix Cannulated Screw 3.0 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

Related Records

Product Codes

CodeName
HWCScrew, Fixation, Bone

Product Code Classifications

CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Premarket Submissions

SubmissionSupplement
K231860000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K231860000TDM Screw SystemTdm Co., Ltd.2024-01-18HWC

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800043918360PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08800043918360088000439183608800043918360

GMDN Terms

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
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

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