FDA.reportPublic FDA data

N/A

Primary DI
08809350898518
Brand
N/A
Company
TDM Co., Ltd.
Model
526-65040
Catalog number
526-65040
Device description
Nail Locking Screw, Ø6.5mm 40mm
Published
2025-02-05
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
K230071000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230071000Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail System, Humerus Interlocking Nail System, Tibia Interlocking Nail System, Compression Hip Nail SystemTdm Co., Ltd.2024-08-22HSB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809350898518PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809350898518088093508985188809350898518

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
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

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