02100020

GUDID H679021000200

2.4MM/2.7MM LOCKING NAVICULAR PLATE

Synthes GmbH

Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable
Primary Device IDH679021000200
NIH Device Record Key01ba00e1-e7ff-4e6a-a33a-da26e05b95a8
Commercial Distribution StatusIn Commercial Distribution
Version Model Number02.100.020
Catalog Number02100020
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
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
GS110886982028280 [Primary]
HIBCCH679021000200 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPLATE, FIXATION, BONE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[H679021000200]

Moist Heat or Steam Sterilization


[H679021000200]

Moist Heat or Steam Sterilization


[H679021000200]

Moist Heat or Steam Sterilization


[H679021000200]

Moist Heat or Steam Sterilization


[H679021000200]

Moist Heat or Steam Sterilization


[H679021000200]

Moist Heat or Steam Sterilization


[H679021000200]

Moist Heat or Steam Sterilization


[H679021000200]

Moist Heat or Steam Sterilization


[H679021000200]

Moist Heat or Steam Sterilization


[H679021000200]

Moist Heat or Steam Sterilization


[H679021000200]

Moist Heat or Steam Sterilization


[H679021000200]

Moist Heat or Steam Sterilization


[H679021000200]

Moist Heat or Steam Sterilization


[H679021000200]

Moist Heat or Steam Sterilization


[H679021000200]

Moist Heat or Steam Sterilization


[H679021000200]

Moist Heat or Steam Sterilization


[H679021000200]

Moist Heat or Steam Sterilization


[H679021000200]

Moist Heat or Steam Sterilization


[H679021000200]

Moist Heat or Steam Sterilization


[H679021000200]

Moist Heat or Steam Sterilization


[H679021000200]

Moist Heat or Steam Sterilization


[H679021000200]

Moist Heat or Steam Sterilization


[H679021000200]

Moist Heat or Steam Sterilization


[H679021000200]

Moist Heat or Steam Sterilization


[H679021000200]

Moist Heat or Steam Sterilization


[H679021000200]

Moist Heat or Steam Sterilization


[H679021000200]

Moist Heat or Steam Sterilization


[H679021000200]

Moist Heat or Steam Sterilization


[H679021000200]

Moist Heat or Steam Sterilization


[H679021000200]

Moist Heat or Steam Sterilization


[H679021000200]

Moist Heat or Steam Sterilization


[H679021000200]

Moist Heat or Steam Sterilization


[H679021000200]

Moist Heat or Steam Sterilization


[H679021000200]

Moist Heat or Steam Sterilization


[H679021000200]

Moist Heat or Steam Sterilization


[H679021000200]

Moist Heat or Steam Sterilization


[H679021000200]

Moist Heat or Steam Sterilization


[H679021000200]

Moist Heat or Steam Sterilization


[H679021000200]

Moist Heat or Steam Sterilization


[H679021000200]

Moist Heat or Steam Sterilization


[H679021000200]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-04-28
Device Publish Date2015-09-14

Devices Manufactured by Synthes GmbH

10887587078311 - NA2024-06-04 PLATE HOLDING FORCEPS WITH BALL AND FOOT
10887587078366 - NA2024-05-22 BONE PUSHER
10886982344229 - NA2024-05-13 FOOT - 10MM UPRIGHT REDUCTION CLAMP
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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.