Bone Screws 10136

GUDID 18032568031287

CORTICAL SCREW 100/30 MM SHAFT D 6MM THREAD D 4.5-3.5MM

ORTHOFIX SRL

Orthopaedic bone pin, non-bioabsorbable
Primary Device ID18032568031287
NIH Device Record Key0a0b9721-1f72-412d-bf75-57c70b340e1f
Commercial Distribution StatusIn Commercial Distribution
Brand NameBone Screws
Version Model Number1
Catalog Number10136
Company DUNS438793622
Company NameORTHOFIX SRL
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 Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+039456719000
Emailinfo@orthofix.it
Phone+039456719000
Emailinfo@orthofix.it
Phone+039456719000
Emailinfo@orthofix.it
Phone+039456719000
Emailinfo@orthofix.it
Phone+039456719000
Emailinfo@orthofix.it
Phone+039456719000
Emailinfo@orthofix.it
Phone+039456719000
Emailinfo@orthofix.it
Phone+039456719000
Emailinfo@orthofix.it
Phone+039456719000
Emailinfo@orthofix.it
Phone+039456719000
Emailinfo@orthofix.it
Phone+039456719000
Emailinfo@orthofix.it
Phone+039456719000
Emailinfo@orthofix.it
Phone+039456719000
Emailinfo@orthofix.it
Phone+039456719000
Emailinfo@orthofix.it
Phone+039456719000
Emailinfo@orthofix.it

Device Dimensions

Device Size Text, specify0
Outer Diameter6 Millimeter
Device Size Text, specify0
Length100 Millimeter
Device Size Text, specify0
Outer Diameter6 Millimeter
Device Size Text, specify0
Length100 Millimeter
Device Size Text, specify0
Outer Diameter6 Millimeter
Device Size Text, specify0
Length100 Millimeter
Device Size Text, specify0
Outer Diameter6 Millimeter
Device Size Text, specify0
Length100 Millimeter
Device Size Text, specify0
Outer Diameter6 Millimeter
Device Size Text, specify0
Length100 Millimeter
Device Size Text, specify0
Outer Diameter6 Millimeter
Device Size Text, specify0
Length100 Millimeter
Device Size Text, specify0
Outer Diameter6 Millimeter
Device Size Text, specify0
Length100 Millimeter
Device Size Text, specify0
Outer Diameter6 Millimeter
Device Size Text, specify0
Length100 Millimeter
Device Size Text, specify0
Outer Diameter6 Millimeter
Device Size Text, specify0
Length100 Millimeter
Device Size Text, specify0
Outer Diameter6 Millimeter
Device Size Text, specify0
Length100 Millimeter
Device Size Text, specify0
Outer Diameter6 Millimeter
Device Size Text, specify0
Length100 Millimeter
Device Size Text, specify0
Outer Diameter6 Millimeter
Device Size Text, specify0
Length100 Millimeter
Device Size Text, specify0
Outer Diameter6 Millimeter
Device Size Text, specify0
Length100 Millimeter
Device Size Text, specify0
Outer Diameter6 Millimeter
Device Size Text, specify0
Length100 Millimeter
Device Size Text, specify0
Outer Diameter6 Millimeter
Device Size Text, specify0
Length100 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS118032568031287 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDWPin, Fixation, Threaded

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[18032568031287]

Moist Heat or Steam Sterilization


[18032568031287]

Moist Heat or Steam Sterilization


[18032568031287]

Moist Heat or Steam Sterilization


[18032568031287]

Moist Heat or Steam Sterilization


[18032568031287]

Moist Heat or Steam Sterilization


[18032568031287]

Moist Heat or Steam Sterilization


[18032568031287]

Moist Heat or Steam Sterilization


[18032568031287]

Moist Heat or Steam Sterilization


[18032568031287]

Moist Heat or Steam Sterilization


[18032568031287]

Moist Heat or Steam Sterilization


[18032568031287]

Moist Heat or Steam Sterilization


[18032568031287]

Moist Heat or Steam Sterilization


[18032568031287]

Moist Heat or Steam Sterilization


[18032568031287]

Moist Heat or Steam Sterilization


[18032568031287]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-16

On-Brand Devices [Bone Screws]

18033509851902SELF-DRILLING CORTICAL SCREW STERILE LENGTH 70/15 MM D 3.0-2.5 MM
18033509851896SELF-DRILLING CANCELLOUS SCREW STERILE LENGTH 90/35 MM D 4.0-3.5 MM
18033509851889SELF-DRILL CORT SCREW 100/30MM STERILE THREAD DIA. 3-2.5 MM
18033509851872SELF-DRILLING CORTICAL SCREW STERILE LENGTH 70/30 MM D 3.0-2.5 MM
18033509851865SELF-DRILLING CORTICAL SCREW STERILE LENGTH 70/25 MM D 3.0-2.5 MM
18033509851858SELF-DRILLING CORTICAL SCREW STERILE LENGTH 70/20 MM D 3.0-2.5 MM
18033509851841SELF-DRILLING CORTICAL SCREW STERILE LENGTH 60/30 MM D 3.0-2.5 MM
18033509851834SELF-DRILLING CORTICAL SCREW STERILE LENGTH 60/25 MM D 3.0-2.5 MM
18033509851827SELF-DRILLING CORTICAL SCREW STERILE LENGTH 60/20 MM D 3.0-2.5 MM
18033509851810SELF-DRILLING CORTICAL SCREW STERILE LENGTH 50/18 MM D 3.0-2.5 MM
18033509851803SELF-DRILLING CORTICAL SCREW STERILE LENGTH 45/20 MM D 2.5-2.0 MM
18033509851797SELF-DRILLING CORTICAL SCREW STERILE LENGTH 40/15 MM D 2.5-2.0 MM
18033509850509SELF-DRILL CORT SCREW 120/40MM STERILE SHAFT D 6MM THREAD D 4.5-3.5MM
18033509850493CORTICAL SCREW 80/20 MM STERILE SHAFT D 6MM THREAD D 4.5-3.5MM
18033509850486CORTICAL SCREW 70/20 MM STERILE SHAFT D 6MM THREAD D 4.5-3.5MM
18033509850462SELF-DRILL CORT SCREW 250/80MM STERILE SHAFT D 6 MM THREAD D 6-5 MM
18033509850455SELF-DRILL CORT SCREW 220/50MM STERILE SHAFT D 6 MM THREAD D 6-5 MM
18033509850448SELF-DRILL CORT SCREW 220/40MM STERILE SHAFT D 6 MM THREAD D 6-5 MM
18033509850431SELF-DRILL CORT SCREW 150/40MM STERILE SHAFT D 6 MM THREAD D 6-5 MM
18033509850424CORTICAL SCREW 200/90 MM STERILE SHAFT D 6 MM THREAD D 6-5 MM
18033509850417CORTICAL SCREW 170/80 MM STERILE SHAFT D 6 MM THREAD D 6-5 MM
18033509850400CORTICAL SCREW 160/70 MM STERILE SHAFT D 6 MM THREAD D 6-5 MM
18033509850394CORTICAL SCREW 150/40 MM STERILE SHAFT D 6 MM THREAD D 6-5 MM
18033509850387CORTICAL SCREW 120/40 MM STERILE SHAFT D 6 MM THREAD D 6-5 MM
18033509850370CORTICAL SCREW 100/40 MM STERILE SHAFT D 6 MM THREAD D 6-5 MM
18033509850363CORTICAL SCREW 100/30 MM STERILE SHAFT D 6 MM THREAD D 6-5 MM
18033509850356CORTICAL SCREW 90/30 MM STERILE SHAFT D 6 MM THREAD D 6-5 MM
18033509850349CORTICAL SCREW 80/30 MM STERILE SHAFT D 6MM THREAD D 3.5-3.2MM
18033509850332CORTICAL SCREW 70/20 MM STERILE SHAFT D 6MM THREAD D 3.5-3.2MM
18033509850325CORTICAL SCREW 170/60 MM STERILE SHAFT D 6 MM THREAD D 6-5 MM
18033509850318CORTICAL SCREW 170/40 MM STERILE SHAFT D 6 MM THREAD D 6-5 MM
18033509850301CORTICAL SCREW 160/50 MM STERILE SHAFT D 6 MM THREAD D 6-5 MM
18033509850295CORTICAL SCREW 150/30 MM STERILE SHAFT D 6 MM THREAD D 6-5 MM
18033509850288CORTICAL SCREW 130/50 MM STERILE SHAFT D 6 MM THREAD D 6-5 MM
18033509850271CORTICAL SCREW 130/30 MM STERILE SHAFT D 6 MM THREAD D 6-5 MM
18033509850264CORTICAL SCREW 120/30 MM STERILE SHAFT D 6MM THREAD D 4.5-3.5MM
18033509850257CORTICAL SCREW 120/20 MM STERILE SHAFT D 6MM THREAD D 4.5-3.5MM
18033509850240CORTICAL SCREW 100/30 MM STERILE SHAFT D 6MM THREAD D 4.5-3.5MM
18033509850233CORTICAL SCREW 100/20 MM STERILE SHAFT D 6MM THREAD D 4.5-3.5MM
18033509850158CORTICAL SCREW 200/60 MM STERILE SHAFT D 6 MM THREAD D 6-5 MM
18033509850141CORTICAL SCREW 200/50 MM STERILE SHAFT D 6 MM THREAD D 6-5 MM
18033509850134CORTICAL SCREW 130/40 MM STERILE SHAFT D 6 MM THREAD D 6-5 MM
18033509850127SELF-DRILL CORT SCREW 150/50MM STERILE SHAFT D 6 MM THREAD D 6-5 MM
18033509850110CORTICAL SCREW 180/60 MM STERILE SHAFT D 6 MM THREAD D 6-5 MM
18033509850103CORTICAL SCREW 150/60 MM STERILE SHAFT D 6 MM THREAD D 6-5 MM
18033509850097CORTICAL SCREW 110/30 MM STERILE SHAFT D 6 MM THREAD D 6-5 MM
18033509850080CORTICAL SCREW 80/30 MM STERILE SHAFT D 6MM THREAD D 4.5-3.5MM
18033509850073CORTICAL SCREW 120/40 MM STERILE SHAFT D 6MM THREAD D 4.5-3.5MM
18033509850066CORTICAL SCREW 100/40 MM STERILE SHAFT D 6MM THREAD D 4.5-3.5MM
18033509850059SELF-DRILL CORT SCREW 220/60MM STERILE SHAFT D 6 MM THREAD D 6-5 MM

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.