235600S

GUDID H679235600S0

90 DEG ADOLESCENT OSTEOTOMY PLATE 50MM/10MM-STERILE

Synthes GmbH

Orthopaedic fixation plate, non-bioabsorbable, sterile
Primary Device IDH679235600S0
NIH Device Record Key8a7ddf8d-1473-4dc1-8053-5a3e5b7d2c45
Commercial Distribution StatusIn Commercial Distribution
Version Model Number235.600S
Catalog Number235600S
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 Datetrue
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
Phone+1(800)255-2500
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS110886982160027 [Primary]
HIBCCH679235600S0 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KTWAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[H679235600S0]

Moist Heat or Steam Sterilization


[H679235600S0]

Moist Heat or Steam Sterilization


[H679235600S0]

Moist Heat or Steam Sterilization


[H679235600S0]

Moist Heat or Steam Sterilization


[H679235600S0]

Moist Heat or Steam Sterilization


[H679235600S0]

Moist Heat or Steam Sterilization


[H679235600S0]

Moist Heat or Steam Sterilization


[H679235600S0]

Moist Heat or Steam Sterilization


[H679235600S0]

Moist Heat or Steam Sterilization


[H679235600S0]

Moist Heat or Steam Sterilization


[H679235600S0]

Moist Heat or Steam Sterilization


[H679235600S0]

Moist Heat or Steam Sterilization


[H679235600S0]

Moist Heat or Steam Sterilization


[H679235600S0]

Moist Heat or Steam Sterilization


[H679235600S0]

Moist Heat or Steam Sterilization


[H679235600S0]

Moist Heat or Steam Sterilization


[H679235600S0]

Moist Heat or Steam Sterilization


[H679235600S0]

Moist Heat or Steam Sterilization


[H679235600S0]

Moist Heat or Steam Sterilization


[H679235600S0]

Moist Heat or Steam Sterilization


[H679235600S0]

Moist Heat or Steam Sterilization


[H679235600S0]

Moist Heat or Steam Sterilization


[H679235600S0]

Moist Heat or Steam Sterilization


[H679235600S0]

Moist Heat or Steam Sterilization


[H679235600S0]

Moist Heat or Steam Sterilization


[H679235600S0]

Moist Heat or Steam Sterilization


[H679235600S0]

Moist Heat or Steam Sterilization


[H679235600S0]

Moist Heat or Steam Sterilization


[H679235600S0]

Moist Heat or Steam Sterilization


[H679235600S0]

Moist Heat or Steam Sterilization


[H679235600S0]

Moist Heat or Steam Sterilization


[H679235600S0]

Moist Heat or Steam Sterilization


[H679235600S0]

Moist Heat or Steam Sterilization


[H679235600S0]

Moist Heat or Steam Sterilization


[H679235600S0]

Moist Heat or Steam Sterilization


[H679235600S0]

Moist Heat or Steam Sterilization


[H679235600S0]

Moist Heat or Steam Sterilization


[H679235600S0]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-04-29
Device Publish Date2015-09-14

Devices Manufactured by Synthes GmbH

10886982350039 - NA2025-08-15 CRE DRILL GUIDE 15MM
10886982350046 - NA2025-08-15 CRE DRILL GUIDE 18MM
10886982350053 - NA2025-08-15 CRE DRILL GUIDE 20MM
10886982350060 - NA2025-08-15 CRE DRILL GUIDE 25MM
10886982350077 - NA2025-08-15 7.0MM CAN TAP LARGE QUICK COUPLING
07612334226747 - NA2025-07-31 LID 2/3 SIZE STAINLESS STEEL
07612334227980 - NA2025-07-31 TRAY FOR OPERACE, 1 FROM 2
07612334228352 - NA2025-07-31 TRAY FOR OPERACE, 2 FROM 2

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