494783

GUDID H6794947830

5.0MM TI SELF-DRILLING SCHANZ SCREW 40MM THRD/125MM

Synthes GmbH

Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device IDH6794947830
NIH Device Record Key8d29d51a-22af-45f4-acd2-5af076519732
Commercial Distribution StatusIn Commercial Distribution
Version Model Number494.783
Catalog Number494783
Company DUNS486711679
Company NameSynthes GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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

Device Identifiers

Device Issuing AgencyDevice ID
GS110886982236647 [Primary]
HIBCCH6794947830 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KTTAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[H6794947830]

Moist Heat or Steam Sterilization


[H6794947830]

Moist Heat or Steam Sterilization


[H6794947830]

Moist Heat or Steam Sterilization


[H6794947830]

Moist Heat or Steam Sterilization


[H6794947830]

Moist Heat or Steam Sterilization


[H6794947830]

Moist Heat or Steam Sterilization


[H6794947830]

Moist Heat or Steam Sterilization


[H6794947830]

Moist Heat or Steam Sterilization


[H6794947830]

Moist Heat or Steam Sterilization


[H6794947830]

Moist Heat or Steam Sterilization


[H6794947830]

Moist Heat or Steam Sterilization


[H6794947830]

Moist Heat or Steam Sterilization


[H6794947830]

Moist Heat or Steam Sterilization


[H6794947830]

Moist Heat or Steam Sterilization


[H6794947830]

Moist Heat or Steam Sterilization


[H6794947830]

Moist Heat or Steam Sterilization


[H6794947830]

Moist Heat or Steam Sterilization


[H6794947830]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-05-26
Device Publish Date2015-09-14

Devices Manufactured by Synthes GmbH

10886982313690 - VOLT2025-04-03 3.5 VOLT(TM) PROX HUM PLATE 3H/93MM
10886982313706 - VOLT2025-04-03 3.5 VOLT(TM) PROX HUM PLATE 3H/93MM/STERILE
10886982313713 - VOLT2025-04-03 3.5 VOLT(TM) PROX HUM PLATE 5H/119MM
10886982313720 - VOLT2025-04-03 3.5 VOLT(TM) PROX HUM PLATE 5H/119MM/STERILE
10886982313737 - VOLT2025-04-03 3.5 VOLT(TM) PROX HUM PLATE 3H/93MM
10886982313744 - VOLT2025-04-03 3.5 VOLT(TM) PROX HUM PLATE 3H/93MM/STERILE
10886982313751 - VOLT2025-04-03 3.5 VOLT(TM) PROX HUM PLATE 5H/119MM
10886982313768 - VOLT2025-04-03 3.5 VOLT(TM) PROX HUM PLATE 5H/119MM/STERILE

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.