43961

GUDID H679439610

90 DEG TI ADULT OSTEOTOMY PLATE 55MM/20MM

SYNTHES (U.S.A.) LP

Orthopaedic fixation plate, non-bioabsorbable
Primary Device IDH679439610
NIH Device Record Keyf76d8345-9b20-4ace-b82f-0f28776c90fd
Commercial Distribution Discontinuation2018-06-30
Commercial Distribution StatusNot in Commercial Distribution
Version Model Number439.61
Catalog Number43961
Company DUNS832637081
Company NameSYNTHES (U.S.A.) LP
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
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
GS110886982218889 [Primary]
HIBCCH679439610 [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 Sterilefalse

[H679439610]

Moist Heat or Steam Sterilization


[H679439610]

Moist Heat or Steam Sterilization


[H679439610]

Moist Heat or Steam Sterilization


[H679439610]

Moist Heat or Steam Sterilization


[H679439610]

Moist Heat or Steam Sterilization


[H679439610]

Moist Heat or Steam Sterilization


[H679439610]

Moist Heat or Steam Sterilization


[H679439610]

Moist Heat or Steam Sterilization


[H679439610]

Moist Heat or Steam Sterilization


[H679439610]

Moist Heat or Steam Sterilization


[H679439610]

Moist Heat or Steam Sterilization


[H679439610]

Moist Heat or Steam Sterilization


[H679439610]

Moist Heat or Steam Sterilization


[H679439610]

Moist Heat or Steam Sterilization


[H679439610]

Moist Heat or Steam Sterilization


[H679439610]

Moist Heat or Steam Sterilization


[H679439610]

Moist Heat or Steam Sterilization


[H679439610]

Moist Heat or Steam Sterilization


[H679439610]

Moist Heat or Steam Sterilization


[H679439610]

Moist Heat or Steam Sterilization


[H679439610]

Moist Heat or Steam Sterilization


[H679439610]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2023-09-18
Device Publish Date2015-09-14

Devices Manufactured by SYNTHES (U.S.A.) LP

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10886982293237 - NA2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 30MM/ XL25
10886982293244 - NA2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 32MM/ XL25
10886982293251 - NA2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 34MM/ XL25
10886982293268 - NA2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 36MM/ XL25
10886982293275 - NA2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 38MM/ XL25
10886982293282 - NA2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 40MM/ XL25
10886982293299 - NA2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 42MM/ XL25

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