40151296

GUDID H679401512960

2.4MM TI CORTEX SCREW SELF-TAPPING 12MM

Synthes GmbH

Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device IDH679401512960
NIH Device Record Keya2940376-efb4-4eba-b45b-81e3d6340d32
Commercial Distribution StatusIn Commercial Distribution
Version Model Number401.512.96
Catalog Number40151296
Company DUNS486711679
Company NameSynthes GmbH
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS110886982204349 [Primary]
HIBCCH679401512960 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JEYPLATE, BONE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[H679401512960]

Moist Heat or Steam Sterilization


[H679401512960]

Moist Heat or Steam Sterilization


[H679401512960]

Moist Heat or Steam Sterilization


[H679401512960]

Moist Heat or Steam Sterilization


[H679401512960]

Moist Heat or Steam Sterilization


[H679401512960]

Moist Heat or Steam Sterilization


[H679401512960]

Moist Heat or Steam Sterilization


[H679401512960]

Moist Heat or Steam Sterilization


[H679401512960]

Moist Heat or Steam Sterilization


[H679401512960]

Moist Heat or Steam Sterilization


[H679401512960]

Moist Heat or Steam Sterilization


[H679401512960]

Moist Heat or Steam Sterilization


[H679401512960]

Moist Heat or Steam Sterilization


[H679401512960]

Moist Heat or Steam Sterilization


[H679401512960]

Moist Heat or Steam Sterilization


[H679401512960]

Moist Heat or Steam Sterilization


[H679401512960]

Moist Heat or Steam Sterilization


[H679401512960]

Moist Heat or Steam Sterilization


[H679401512960]

Moist Heat or Steam Sterilization


[H679401512960]

Moist Heat or Steam Sterilization


[H679401512960]

Moist Heat or Steam Sterilization


[H679401512960]

Moist Heat or Steam Sterilization


[H679401512960]

Moist Heat or Steam Sterilization


[H679401512960]

Moist Heat or Steam Sterilization


[H679401512960]

Moist Heat or Steam Sterilization


[H679401512960]

Moist Heat or Steam Sterilization


[H679401512960]

Moist Heat or Steam Sterilization


[H679401512960]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-05-02
Device Publish Date2015-09-14

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07612334268679 - KINCISE2024-11-08 KINCISE(TM) SYSTEM PRIMARY HIP ADAPTER CASE
07612334268563 - KINCISE2024-11-04 KINCISE™ System Automated Surgical Handpiece V2
07612334268570 - KINCISE2024-11-04 KINCISE™ System Lithium-ion Battery
07612334268594 - KINCISE2024-11-04 KINCISE™ System Primary Hip PINNACLE™ Straight Shell/Liner Impactor - Long
07612334268600 - KINCISE2024-11-04 KINCISE™ System Primary Hip PINNACLE™ Offset Shell/Liner Impactor
07612334268617 - KINCISE2024-11-04 KINCISE™ System Primary Hip PINNACLE™ Inclination Guide

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