03402724

GUDID H679034027240

9MM BROACH/CURVED TIP FOR RADIAL HEAD PROSTHESIS

Synthes GmbH

Elbow radius prosthesis
Primary Device IDH679034027240
NIH Device Record Key0da6e822-60ea-4e01-bef6-4b265840707f
Commercial Distribution StatusIn Commercial Distribution
Version Model Number03.402.724
Catalog Number03402724
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 Usefalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS107611819509283 [Direct Marking]
GS110886982080325 [Primary]
HIBCCH679034027240 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWIPROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[H679034027240]

Moist Heat or Steam Sterilization


[H679034027240]

Moist Heat or Steam Sterilization


[H679034027240]

Moist Heat or Steam Sterilization


[H679034027240]

Moist Heat or Steam Sterilization


[H679034027240]

Moist Heat or Steam Sterilization


[H679034027240]

Moist Heat or Steam Sterilization


[H679034027240]

Moist Heat or Steam Sterilization


[H679034027240]

Moist Heat or Steam Sterilization


[H679034027240]

Moist Heat or Steam Sterilization


[H679034027240]

Moist Heat or Steam Sterilization


[H679034027240]

Moist Heat or Steam Sterilization


[H679034027240]

Moist Heat or Steam Sterilization


[H679034027240]

Moist Heat or Steam Sterilization


[H679034027240]

Moist Heat or Steam Sterilization


[H679034027240]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2022-04-28
Device Publish Date2015-09-14

Devices Manufactured by Synthes GmbH

07611819642669 - NA2025-06-27 130 DEG AIMING ARM STATIC+DYNAMIC DISTAL LOCKING
07611819642676 - NA2025-06-27 125 DEG AIMING ARM STATIC+DYNAMIC DISTAL LOCKING
07611819655522 - NA2025-06-27 135 DEG AIMING ARM STATIC+DYNAMIC DISTAL LOCKING
10886982348159 - NA2025-06-27 5.0MM BLUNTED POINT SCHANZ SCREW 45MM THRD/175MM/HA STER
10886982348166 - NA2025-06-27 5.0MM BLUNTED POINT SCHANZ SCREW 45MM THRD/250MM/HA STER
10886982348173 - NA2025-06-27 5.0MM BLUNTED POINT SCHANZ SCREW 50MM THRD/175MM/HA STER
10886982348180 - NA2025-06-27 5.0MM BLUNTED POINT SCHANZ SCREW 50MM THRD/250MM/HA STER
10886982348197 - NA2025-06-27 6.0MM BLUNTED POINT SCHANZ SCREW 45MM THRD/175MM/HA STER

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