422349

GUDID H6794223490

TI DISTAL FEMUR LISS PLATE 13 HOLES/316MM-LEFT

Synthes GmbH

Orthopaedic fixation plate, non-bioabsorbable, sterile
Primary Device IDH6794223490
NIH Device Record Key11631134-f1b3-447c-adaa-4dc147a6d966
Commercial Distribution StatusIn Commercial Distribution
Version Model Number422.349
Catalog Number422349
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
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
GS110886982215819 [Primary]
HIBCCH6794223490 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPLATE, FIXATION, BONE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[H6794223490]

Moist Heat or Steam Sterilization


[H6794223490]

Moist Heat or Steam Sterilization


[H6794223490]

Moist Heat or Steam Sterilization


[H6794223490]

Moist Heat or Steam Sterilization


[H6794223490]

Moist Heat or Steam Sterilization


[H6794223490]

Moist Heat or Steam Sterilization


[H6794223490]

Moist Heat or Steam Sterilization


[H6794223490]

Moist Heat or Steam Sterilization


[H6794223490]

Moist Heat or Steam Sterilization


[H6794223490]

Moist Heat or Steam Sterilization


[H6794223490]

Moist Heat or Steam Sterilization


[H6794223490]

Moist Heat or Steam Sterilization


[H6794223490]

Moist Heat or Steam Sterilization


[H6794223490]

Moist Heat or Steam Sterilization


[H6794223490]

Moist Heat or Steam Sterilization


[H6794223490]

Moist Heat or Steam Sterilization


[H6794223490]

Moist Heat or Steam Sterilization


[H6794223490]

Moist Heat or Steam Sterilization


[H6794223490]

Moist Heat or Steam Sterilization


[H6794223490]

Moist Heat or Steam Sterilization


[H6794223490]

Moist Heat or Steam Sterilization


[H6794223490]

Moist Heat or Steam Sterilization


[H6794223490]

Moist Heat or Steam Sterilization


[H6794223490]

Moist Heat or Steam Sterilization


[H6794223490]

Moist Heat or Steam Sterilization


[H6794223490]

Moist Heat or Steam Sterilization


[H6794223490]

Moist Heat or Steam Sterilization


[H6794223490]

Moist Heat or Steam Sterilization


[H6794223490]

Moist Heat or Steam Sterilization


[H6794223490]

Moist Heat or Steam Sterilization


[H6794223490]

Moist Heat or Steam Sterilization


[H6794223490]

Moist Heat or Steam Sterilization


[H6794223490]

Moist Heat or Steam Sterilization


[H6794223490]

Moist Heat or Steam Sterilization


[H6794223490]

Moist Heat or Steam Sterilization


[H6794223490]

Moist Heat or Steam Sterilization


[H6794223490]

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

Devices Manufactured by Synthes GmbH

07612334260079 - KINCISE2024-11-08 KINCISE(TM) SYSTEM SURGICAL HANDPIECE CASE
07612334268587 - KINCISE2024-11-08 KINCISE(TM) SYSTEM STERILIZATION CASE LID
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

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