04226756

GUDID H679042267560

4.5MM TI HEADLESS COMPRESSION SCREW/LONG THREAD/56MM

Synthes GmbH

Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding)
Primary Device IDH679042267560
NIH Device Record Key011fec4b-18ec-42ce-a95e-d2bb602e37b3
Commercial Distribution StatusIn Commercial Distribution
Version Model Number04.226.756
Catalog Number04226756
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

Device Identifiers

Device Issuing AgencyDevice ID
GS110886982124081 [Primary]
HIBCCH679042267560 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, fixation, bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[H679042267560]

Moist Heat or Steam Sterilization


[H679042267560]

Moist Heat or Steam Sterilization


[H679042267560]

Moist Heat or Steam Sterilization


[H679042267560]

Moist Heat or Steam Sterilization


[H679042267560]

Moist Heat or Steam Sterilization


[H679042267560]

Moist Heat or Steam Sterilization


[H679042267560]

Moist Heat or Steam Sterilization


[H679042267560]

Moist Heat or Steam Sterilization


[H679042267560]

Moist Heat or Steam Sterilization


[H679042267560]

Moist Heat or Steam Sterilization


[H679042267560]

Moist Heat or Steam Sterilization


[H679042267560]

Moist Heat or Steam Sterilization


[H679042267560]

Moist Heat or Steam Sterilization


[H679042267560]

Moist Heat or Steam Sterilization


[H679042267560]

Moist Heat or Steam Sterilization


[H679042267560]

Moist Heat or Steam Sterilization


[H679042267560]

Moist Heat or Steam Sterilization


[H679042267560]

Moist Heat or Steam Sterilization


[H679042267560]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-05-27
Device Publish Date2015-09-14

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10886982344236 - NA2024-05-13 FOOT - 4MM UPRIGHT REDUCTION CLAMP
10886982344243 - NA2024-05-13 HOOK - 4MM UPRIGHT REDUCTION CLAMP
10886982344250 - NA2024-05-13 HOOK - 10MM UPRIGHT REDUCTION CLAMP
10886982346940 - NA2024-05-09 60MM DEPTH PROBE FOR XL25 SCREWS
10886982346933 - NA2024-05-08 EXTENDED MULTI HOLE WIRE GUIDE FOR RFNA

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