ANTEGRA 04103147

GUDID H981041031470

TI ANTEGRA(TM) PLATE ONE LEVEL SACRAL/47MM

Synthes GmbH

Bone-screw internal spinal fixation system, non-sterile
Primary Device IDH981041031470
NIH Device Record Keyb85ac03a-760a-45f8-8a45-15c297090d25
Commercial Distribution StatusIn Commercial Distribution
Brand NameANTEGRA
Version Model Number04.103.147
Catalog Number04103147
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

Device Identifiers

Device Issuing AgencyDevice ID
GS110705034733302 [Primary]
HIBCCH981041031470 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[H981041031470]

Moist Heat or Steam Sterilization

[H981041031470]

Moist Heat or Steam Sterilization

[H981041031470]

Moist Heat or Steam Sterilization

[H981041031470]

Moist Heat or Steam Sterilization

[H981041031470]

Moist Heat or Steam Sterilization

[H981041031470]

Moist Heat or Steam Sterilization

[H981041031470]

Moist Heat or Steam Sterilization

[H981041031470]

Moist Heat or Steam Sterilization

[H981041031470]

Moist Heat or Steam Sterilization

[H981041031470]

Moist Heat or Steam Sterilization

[H981041031470]

Moist Heat or Steam Sterilization

[H981041031470]

Moist Heat or Steam Sterilization

[H981041031470]

Moist Heat or Steam Sterilization

[H981041031470]

Moist Heat or Steam Sterilization

[H981041031470]

Moist Heat or Steam Sterilization

[H981041031470]

Moist Heat or Steam Sterilization

[H981041031470]

Moist Heat or Steam Sterilization

[H981041031470]

Moist Heat or Steam Sterilization

[H981041031470]

Moist Heat or Steam Sterilization

[H981041031470]

Moist Heat or Steam Sterilization

[H981041031470]

Moist Heat or Steam Sterilization

[H981041031470]

Moist Heat or Steam Sterilization

[H981041031470]

Moist Heat or Steam Sterilization

[H981041031470]

Moist Heat or Steam Sterilization

[H981041031470]

Moist Heat or Steam Sterilization

[H981041031470]

Moist Heat or Steam Sterilization

[H981041031470]

Moist Heat or Steam Sterilization

[H981041031470]

Moist Heat or Steam Sterilization

[H981041031470]

Moist Heat or Steam Sterilization

[H981041031470]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-04-26
Device Publish Date2015-09-14

On-Brand Devices [ANTEGRA]

H981041033110TI ANTEGRA(TM) PLATE TWO LEVEL SACRAL/111MM
H981041033070TI ANTEGRA(TM) PLATE TWO LEVEL SACRAL/107MM
H981041033030TI ANTEGRA(TM) PLATE TWO LEVEL SACRAL/103MM
H981041032990TI ANTEGRA(TM) PLATE TWO LEVEL SACRAL/99MM
H981041032950TI ANTEGRA(TM) PLATE TWO LEVEL SACRAL/95MM
H981041032910TI ANTEGRA(TM) PLATE TWO LEVEL SACRAL/91MM
H981041032870TI ANTEGRA(TM) PLATE TWO LEVEL SACRAL/87MM
H981041032830TI ANTEGRA(TM) PLATE TWO LEVEL SACRAL/83MM
H981041032790TI ANTEGRA(TM) PLATE TWO LEVEL SACRAL/79MM
H981041031530TI ANTEGRA(TM) PLATE ONE LEVEL SACRAL/53MM
H981041031510TI ANTEGRA(TM) PLATE ONE LEVEL SACRAL/51MM
H981041031490TI ANTEGRA(TM) PLATE ONE LEVEL SACRAL/49MM
H981041031470TI ANTEGRA(TM) PLATE ONE LEVEL SACRAL/47MM
H981041031450TI ANTEGRA(TM) PLATE ONE LEVEL SACRAL/45MM
H981041031430TI ANTEGRA(TM) PLATE ONE LEVEL SACRAL/43MM
H981041031410TI ANTEGRA(TM) PLATE ONE LEVEL SACRAL/41MM
H981041031390TI ANTEGRA(TM) PLATE ONE LEVEL SACRAL/39MM
H981041031370TI ANTEGRA(TM) PLATE ONE LEVEL SACRAL/37MM
H981041023110TI ANTEGRA(TM) PLATE TWO LEVEL LUMBAR/111MM
H981041023070TI ANTEGRA(TM) PLATE TWO LEVEL LUMBAR/107MM
H981041023030TI ANTEGRA(TM) PLATE TWO LEVEL LUMBAR/103MM
H981041022990TI ANTEGRA(TM) PLATE TWO LEVEL LUMBAR/99MM
H981041022950TI ANTEGRA(TM) PLATE TWO LEVEL LUMBAR/95MM
H981041022910TI ANTEGRA(TM) PLATE TWO LEVEL LUMBAR/91MM
H981041022870TI ANTEGRA(TM) PLATE TWO LEVEL LUMBAR/87MM
H981041022830TI ANTEGRA(TM) PLATE TWO LEVEL LUMBAR/83MM
H981041022790TI ANTEGRA(TM) PLATE TWO LEVEL LUMBAR/79MM
H981041021530TI ANTEGRA(TM) PLATE ONE LEVEL LUMBAR/53MM
H981041021510TI ANTEGRA(TM) PLATE ONE LEVEL LUMBAR/51MM
H981041021490TI ANTEGRA(TM) PLATE ONE LEVEL LUMBAR/49MM
H981041021470TI ANTEGRA(TM) PLATE ONE LEVEL LUMBAR/47MM
H981041021450TI ANTEGRA(TM) PLATE ONE LEVEL LUMBAR/45MM
H981041021430TI ANTEGRA(TM) PLATE ONE LEVEL LUMBAR/43MM
H981041021410TI ANTEGRA(TM) PLATE ONE LEVEL LUMBAR/41MM
H981041021390TI ANTEGRA(TM) PLATE ONE LEVEL LUMBAR/39MM
H981041021370TI ANTEGRA(TM) PLATE ONE LEVEL LUMBAR/37MM
H981SD3910080AWL FOR ANTEGRA WITH U-JOINT
H981SD3910070SCREWDRIVER FOR ANTEGRA WITH U-JOINT AND T25 TIP
H981SD3898210T25 STARDRIVE SCREWDRIVER FOR ANTEGRA HOLDING SLEEVE-LONG
H981SD3898200HOLDING SLEEVE FOR ANTEGRA SCREWS
H981SD3120130ANTEGRA AWL-CENTERING WITH STOP
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