04111165

GUDID H679041111650

6.5MM TI MIDFOOT FUSION BOLT 65MM

Synthes GmbH

Orthopaedic bone bolt
Primary Device IDH679041111650
NIH Device Record Key7d9ae38a-3014-4546-861a-0d19b0d4e587
Commercial Distribution StatusIn Commercial Distribution
Version Model Number04.111.165
Catalog Number04111165
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

Device Identifiers

Device Issuing AgencyDevice ID
GS110886982101105 [Primary]
HIBCCH679041111650 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, fixation, bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[H679041111650]

Moist Heat or Steam Sterilization


[H679041111650]

Moist Heat or Steam Sterilization


[H679041111650]

Moist Heat or Steam Sterilization


[H679041111650]

Moist Heat or Steam Sterilization


[H679041111650]

Moist Heat or Steam Sterilization


[H679041111650]

Moist Heat or Steam Sterilization


[H679041111650]

Moist Heat or Steam Sterilization


[H679041111650]

Moist Heat or Steam Sterilization


[H679041111650]

Moist Heat or Steam Sterilization


[H679041111650]

Moist Heat or Steam Sterilization


[H679041111650]

Moist Heat or Steam Sterilization


[H679041111650]

Moist Heat or Steam Sterilization


[H679041111650]

Moist Heat or Steam Sterilization


[H679041111650]

Moist Heat or Steam Sterilization


[H679041111650]

Moist Heat or Steam Sterilization


[H679041111650]

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

H6792050550 - NA2025-02-20 3.5MM CANNULATED SCREW PARTIALLY THREADED/55MM
H6794089050 - NA2025-02-20 7.3MM TI CANNULATED SCREW 16MM THREAD/105MM
07612334285515 - VOLT2024-12-19 VOLT(TM) PROX HUM IMP & INSTR 1 HIGH 3/3 WIDTH ALUM TRAY
10886982346896 - MAXFRAME2024-12-17 MAXFRAME AUTOSTRUT (TM) SOFTWARE
10886982347572 - NA2024-12-11 RFN-ADVANCED POLYMER INLAY STERILE
10886982330994 - VOLT2024-11-22 2.0MM VOLT(TM) ADAPTION PLATE 12H/65MM
07612334260079 - KINCISE2024-11-08 KINCISE(TM) SYSTEM SURGICAL HANDPIECE CASE
07612334268587 - KINCISE2024-11-08 KINCISE(TM) SYSTEM STERILIZATION CASE LID

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