N/A 213500-1055

GUDID 08800043908316

3.5mm Cortical Screw, Low Profile Head *55mm

TDM Co., Ltd.

Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device ID08800043908316
NIH Device Record Keyd2c4a440-e8c3-42dc-a191-e19e54570189
Commercial Distribution StatusIn Commercial Distribution
Brand NameN/A
Version Model Number213500-1055
Catalog Number213500-1055
Company DUNS557801921
Company NameTDM Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Length55 Millimeter
Outer Diameter3.5 Millimeter
Length55 Millimeter
Outer Diameter3.5 Millimeter
Length55 Millimeter
Outer Diameter3.5 Millimeter
Length55 Millimeter
Outer Diameter3.5 Millimeter
Length55 Millimeter
Outer Diameter3.5 Millimeter
Length55 Millimeter
Outer Diameter3.5 Millimeter
Length55 Millimeter
Outer Diameter3.5 Millimeter
Length55 Millimeter
Outer Diameter3.5 Millimeter
Length55 Millimeter
Outer Diameter3.5 Millimeter
Length55 Millimeter
Outer Diameter3.5 Millimeter
Length55 Millimeter
Outer Diameter3.5 Millimeter
Length55 Millimeter
Outer Diameter3.5 Millimeter
Length55 Millimeter
Outer Diameter3.5 Millimeter
Length55 Millimeter
Outer Diameter3.5 Millimeter
Length55 Millimeter
Outer Diameter3.5 Millimeter
Length55 Millimeter
Outer Diameter3.5 Millimeter
Length55 Millimeter
Outer Diameter3.5 Millimeter
Length55 Millimeter
Outer Diameter3.5 Millimeter
Length55 Millimeter
Outer Diameter3.5 Millimeter
Length55 Millimeter
Outer Diameter3.5 Millimeter
Length55 Millimeter
Outer Diameter3.5 Millimeter
Length55 Millimeter
Outer Diameter3.5 Millimeter
Length55 Millimeter
Outer Diameter3.5 Millimeter
Length55 Millimeter
Outer Diameter3.5 Millimeter
Length55 Millimeter
Outer Diameter3.5 Millimeter
Length55 Millimeter
Outer Diameter3.5 Millimeter
Length55 Millimeter
Outer Diameter3.5 Millimeter
Length55 Millimeter
Outer Diameter3.5 Millimeter
Length55 Millimeter
Outer Diameter3.5 Millimeter
Length55 Millimeter
Outer Diameter3.5 Millimeter
Length55 Millimeter
Outer Diameter3.5 Millimeter
Length55 Millimeter
Outer Diameter3.5 Millimeter
Length55 Millimeter
Outer Diameter3.5 Millimeter
Length55 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS108800043908316 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800043908316]

Moist Heat or Steam Sterilization


[08800043908316]

Moist Heat or Steam Sterilization


[08800043908316]

Moist Heat or Steam Sterilization


[08800043908316]

Moist Heat or Steam Sterilization


[08800043908316]

Moist Heat or Steam Sterilization


[08800043908316]

Moist Heat or Steam Sterilization


[08800043908316]

Moist Heat or Steam Sterilization


[08800043908316]

Moist Heat or Steam Sterilization


[08800043908316]

Moist Heat or Steam Sterilization


[08800043908316]

Moist Heat or Steam Sterilization


[08800043908316]

Moist Heat or Steam Sterilization


[08800043908316]

Moist Heat or Steam Sterilization


[08800043908316]

Moist Heat or Steam Sterilization


[08800043908316]

Moist Heat or Steam Sterilization


[08800043908316]

Moist Heat or Steam Sterilization


[08800043908316]

Moist Heat or Steam Sterilization


[08800043908316]

Moist Heat or Steam Sterilization


[08800043908316]

Moist Heat or Steam Sterilization


[08800043908316]

Moist Heat or Steam Sterilization


[08800043908316]

Moist Heat or Steam Sterilization


[08800043908316]

Moist Heat or Steam Sterilization


[08800043908316]

Moist Heat or Steam Sterilization


[08800043908316]

Moist Heat or Steam Sterilization


[08800043908316]

Moist Heat or Steam Sterilization


[08800043908316]

Moist Heat or Steam Sterilization


[08800043908316]

Moist Heat or Steam Sterilization


[08800043908316]

Moist Heat or Steam Sterilization


[08800043908316]

Moist Heat or Steam Sterilization


[08800043908316]

Moist Heat or Steam Sterilization


[08800043908316]

Moist Heat or Steam Sterilization


[08800043908316]

Moist Heat or Steam Sterilization


[08800043908316]

Moist Heat or Steam Sterilization


[08800043908316]

Moist Heat or Steam Sterilization


[08800043908316]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-01-20
Device Publish Date2020-01-10

On-Brand Devices [N/A]

088093198463692.0mm Cortical Screw*6mm
088093198419132.0mm Cortical Screw*20mm
088093198419062.0mm Cortical Screw*18mm
088093198418902.0mm Cortical Screw*16mm
088093198418832.0mm Cortical Screw*14mm
088093198418762.0mm Cortical Screw*12mm
08809319841869220-21010
088093198418522.0mm Cortical Screw*8mm
08809517537236Clavicle Locking Plate, Mid Shaft *Rt/6H
08809517537229Clavicle Locking Plate, Mid Shaft *Rt/5H
08809517537212Clavicle Locking Plate, Mid Shaft *Lt/6H
08809517537205Clavicle Locking Plate, Mid Shaft *Lt/5H
08809517536994Distal Tibia Locking Plate, Medial, Hook *4H
08809517536987Distal Tibia Locking Plate, Medial, Hook *3H
08809517536963Clavicle Locking Plate, Distal *Rt/7H
08809517536956Clavicle Locking Plate, Distal *Rt/6H
08809517536949Clavicle Locking Plate, Distal *Lt/7H
08809517536932Clavicle Locking Plate, Distal *Lt/6H
08809517536482Distal Tibia Locking Plate, Medial *4H
08809517536475Distal Tibia Locking Plate, Medial *3H
08809517536468Fibular Locking Plate, Lateral *Rt/7H
08809517536451Fibular Locking Plate, Lateral *Rt/5H
08809517536444Fibular Locking Plate, Lateral *Rt/4H
08809517536437Fibular Locking Plate, Lateral *Rt/3H
08809517536420Fibular Locking Plate, Lateral *Lt/7H
08809517536413Fibular Locking Plate, Lateral *Lt/5H
08809517536406Fibular Locking Plate, Lateral *Lt/4H
08809517536390Fibular Locking Plate, Lateral *Lt/3H
08809517536345Distal Tibia Locking Plate, Anterior *Rt/6H
08809517536338Distal Tibia Locking Plate, Anterior *Rt/5H
08809517536321Distal Tibia Locking Plate, Anterior *Rt/4H
08809517536314Distal Tibia Locking Plate, Anterior *Rt/3H
08809517536307Distal Tibia Locking Plate, Anterior *Lt/6H
08809517536291Distal Tibia Locking Plate, Anterior *Lt/5H
08809517536284Distal Tibia Locking Plate, Anterior *Lt/4H
08809517536277Distal Tibia Locking Plate, Anterior *Lt/3H
08809517535812Fibular Locking Plate, Posterior *Rt/5H
08809517535805Fibular Locking Plate, Posterior *Rt/4H
08809517535799Fibular Locking Plate, Posterior *Rt/3H
08809517535782Fibular Locking Plate, Posterior *Lt/5H
08809517535775Fibular Locking Plate, Posterior *Lt/4H
08809517535768Fibular Locking Plate, Posterior *Lt/3H
08809517535621Clavicle Locking Plate, Distal Hook *Rt/3H, 12mm
08809517535614Clavicle Locking Plate, Distal Hook *Lt/3H, 12mm
08809517535607Clavicle Locking Plate, Distal Hook *Rt/4H, 18mm
08809517535591Clavicle Locking Plate, Distal Hook *Lt/4H, 18mm
08809517535584Clavicle Locking Plate, Distal Hook *Rt/3H, 18mm
08809517535577Clavicle Locking Plate, Distal Hook *Lt/3H, 15mm
08809517535560Clavicle Locking Plate, Distal Hook *Lt/3H, 18mm
08809517535478Clavicle Locking Plate, Anterior *8H

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