ATB 449106

GUDID H9814491060

TI ANTERIOR TENSION BAND PLATE TWO LEVEL SACRAL/97MM

SYNTHES (U.S.A.) LP

Spinal fixation plate, non-bioabsorbable
Primary Device IDH9814491060
NIH Device Record Keyae5060ee-04df-4ed9-8224-92c9766aaa37
Commercial Distribution Discontinuation2020-12-19
Commercial Distribution StatusNot in Commercial Distribution
Brand NameATB
Version Model Number449.106
Catalog Number449106
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

Device Identifiers

Device Issuing AgencyDevice ID
GS110705034780290 [Primary]
HIBCCH9814491060 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[H9814491060]

Moist Heat or Steam Sterilization

[H9814491060]

Moist Heat or Steam Sterilization

[H9814491060]

Moist Heat or Steam Sterilization

[H9814491060]

Moist Heat or Steam Sterilization

[H9814491060]

Moist Heat or Steam Sterilization

[H9814491060]

Moist Heat or Steam Sterilization

[H9814491060]

Moist Heat or Steam Sterilization

[H9814491060]

Moist Heat or Steam Sterilization

[H9814491060]

Moist Heat or Steam Sterilization

[H9814491060]

Moist Heat or Steam Sterilization

[H9814491060]

Moist Heat or Steam Sterilization

[H9814491060]

Moist Heat or Steam Sterilization

[H9814491060]

Moist Heat or Steam Sterilization

[H9814491060]

Moist Heat or Steam Sterilization

[H9814491060]

Moist Heat or Steam Sterilization

[H9814491060]

Moist Heat or Steam Sterilization

[H9814491060]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-07-12
Device Publish Date2015-09-14

On-Brand Devices [ATB]

H9816900840MODULE FOR ANTERIOR TENSION BAND TWO LEVEL LUMBAR PLATES
H9816900830MODULE FOR ANTERIOR TENSION BAND TWO LEVEL SACRAL PLATES
H9816900820MODULE FOR ANTERIOR TENSION BAND ONE LEVEL SACRAL PLATES
H9816900810MODULE FOR ANTERIOR TENSION BAND ONE LEVEL LUMBAR PLATES
H9816900980MODULE F/ANTERIOR TENSION BAND 2 LVL SYMMETRICAL SACRAL PL
H9816900970MODULE F/ANTERIOR TENSION BAND 2 LVL SYMMETRICAL LUMBAR PL
07611819776036GRAPHIC CASE FOR ANTERIOR TENSION BAND IMPLANT SET
07611819776029GRAPHIC CASE FOR ANTERIOR TENSION BAND INSTRUMENT SET
H9814491360TI ANTERIOR TENSION BAND PLATE 2 LVL SYMMETRICAL SACRAL/101M
H9814491350TI ANTERIOR TENSION BAND PLATE 2 LVL SYMMETRICAL SACRAL/97MM
H9814491340TI ANTERIOR TENSION BAND PLATE 2 LVL SYMMETRICAL SACRAL/93MM
H9814491330TI ANTERIOR TENSION BAND PLATE 2 LVL SYMMETRICAL SACRAL/89MM
H9814491320TI ANTERIOR TENSION BAND PLATE 2 LVL SYMMETRICAL SACRAL/85MM
H9814491310TI ANTERIOR TENSION BAND PLATE 2 LVL SYMMETRICAL SACRAL/81MM
H9814491300TI ANTERIOR TENSION BAND PLATE 2 LVL SYMMETRICAL SACRAL/77MM
H9814491280TI ANTERIOR TENSION BAND PLATE 2 LVL SYMMETRICAL LUMBAR/109M
H9814491270TI ANTERIOR TENSION BAND PLATE 2 LVL SYMMETRICAL LUMBAR/105M
H9814491260TI ANTERIOR TENSION BAND PLATE 2 LVL SYMMETRICAL LUMBAR/101M
H9814491250TI ANTERIOR TENSION BAND PLATE 2 LVL SYMMETRICAL LUMBAR/97MM
H9814491240TI ANTERIOR TENSION BAND PLATE 2 LVL SYMMETRICAL LUMBAR/93MM
H9814491230TI ANTERIOR TENSION BAND PLATE 2 LVL SYMMETRICAL LUMBAR/89MM
H9814491220TI ANTERIOR TENSION BAND PLATE 2 LVL SYMMETRICAL LUMBAR/85MM
H9814491210TI ANTERIOR TENSION BAND PLATE 2 LVL SYMMETRICAL LUMBAR/81MM
H9814491200TI ANTERIOR TENSION BAND PLATE 2 LVL SYMMETRICAL LUMBAR/77MM
H9814491070TI ANTERIOR TENSION BAND PLATE TWO LEVEL SACRAL/101MM
H9814491060TI ANTERIOR TENSION BAND PLATE TWO LEVEL SACRAL/97MM
H9814491050TI ANTERIOR TENSION BAND PLATE TWO LEVEL SACRAL/93MM
H9814491040TI ANTERIOR TENSION BAND PLATE TWO LEVEL SACRAL/89MM
H9814491030TI ANTERIOR TENSION BAND PLATE TWO LEVEL SACRAL/85MM
H9814491020TI ANTERIOR TENSION BAND PLATE TWO LEVEL SACRAL/81MM
H9814491010TI ANTERIOR TENSION BAND PLATE TWO LEVEL SACRAL/77MM
H9814490890TI ANTERIOR TENSION BAND PLATE TWO LEVEL LUMBAR/109MM
H9814490880TI ANTERIOR TENSION BAND PLATE TWO LEVEL LUMBAR/105MM
H9814490870TI ANTERIOR TENSION BAND PLATE TWO LEVEL LUMBAR/101MM
H9814490860TI ANTERIOR TENSION BAND PLATE TWO LEVEL LUMBAR/97MM
H9814490850TI ANTERIOR TENSION BAND PLATE TWO LEVEL LUMBAR/93MM
H9814490840TI ANTERIOR TENSION BAND PLATE TWO LEVEL LUMBAR/89MM
H9814490830TI ANTERIOR TENSION BAND PLATE TWO LEVEL LUMBAR/85MM
H9814490820TI ANTERIOR TENSION BAND PLATE TWO LEVEL LUMBAR/81MM
H9814490810TI ANTERIOR TENSION BAND PLATE TWO LEVEL LUMBAR/77MM
H9814490770TI ANTERIOR TENSION BAND PLATE ONE LEVEL SACRAL/47MM
H9814490760TI ANTERIOR TENSION BAND PLATE ONE LEVEL SACRAL/45MM
H9814490750TI ANTERIOR TENSION BAND PLATE ONE LEVEL SACRAL/43MM
H9814490740TI ANTERIOR TENSION BAND PLATE ONE LEVEL SACRAL/41MM
H9814490730TI ANTERIOR TENSION BAND PLATE ONE LEVEL SACRAL/39MM
H9814490720TI ANTERIOR TENSION BAND PLATE ONE LEVEL SACRAL/37MM
H9814490710TI ANTERIOR TENSION BAND PLATE ONE LEVEL SACRAL/35MM
H9814490690TI ANTERIOR TENSION BAND PLATE ONE LEVEL LUMBAR/51MM
H9814490680TI ANTERIOR TENSION BAND PLATE ONE LEVEL LUMBAR/49MM
H9814490670TI ANTERIOR TENSION BAND PLATE ONE LEVEL LUMBAR/47MM
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