ANTEGRA-T 04103053S

GUDID H98104103053S0

TI ANTEGRA-T PLATE-STERILE 53MM-50MM LENGTH-SACRAL

Synthes GmbH

Bone-screw internal spinal fixation system, sterile
Primary Device IDH98104103053S0
NIH Device Record Key055ef795-d078-4c7d-bf3b-68c5df6c114b
Commercial Distribution StatusIn Commercial Distribution
Brand NameANTEGRA-T
Version Model Number04.103.053S
Catalog Number04103053S
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 Datetrue
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
GS110705034733241 [Primary]
HIBCCH98104103053S0 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

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-T]

H98104103053S0TI ANTEGRA-T PLATE-STERILE 53MM-50MM LENGTH-SACRAL
H98104103051S0TI ANTEGRA-T PLATE-STERILE 51MM-48MM LENGTH-SACRAL
H98104103049S0TI ANTEGRA-T PLATE-STERILE 49MM-46MM LENGTH-SACRAL
H98104103047S0TI ANTEGRA-T PLATE-STERILE 47MM-44MM LENGTH-SACRAL
H98104103045S0TI ANTEGRA-T PLATE-STERILE 45MM-42MM LENGTH-SACRAL
H98104103043S0TI ANTEGRA-T PLATE-STERILE 43MM-40MM LENGTH-SACRAL
H98104103041S0TI ANTEGRA-T PLATE-STERILE 41MM-38MM LENGTH-SACRAL
H98104103039S0TI ANTEGRA-T PLATE-STERILE 39MM-37MM LENGTH-SACRAL
H98104103037S0TI ANTEGRA-T PLATE-STERILE 37MM-35MM LENGTH-SACRAL
H98104102053S0TI ANTEGRA-T PLATE-STERILE 53MM-50MM LENGTH-LUMBAR
H98104102051S0TI ANTEGRA-T PLATE-STERILE 51MM-48MM LENGTH-LUMBAR
H98104102049S0TI ANTEGRA-T PLATE-STERILE 49MM-46MM LENGTH-LUMBAR
H98104102047S0TI ANTEGRA-T PLATE-STERILE 47MM-44MM LENGTH-LUMBAR
H98104102045S0TI ANTEGRA-T PLATE-STERILE 45MM-42MM LENGTH-LUMBAR
H98104102043S0TI ANTEGRA-T PLATE-STERILE 43MM-40MM LENGTH-LUMBAR
H98104102041S0TI ANTEGRA-T PLATE-STERILE 41MM-38MM LENGTH-LUMBAR
H98104102039S0TI ANTEGRA-T PLATE-STERILE 39MM-37MM LENGTH-LUMBAR
H98104102037S0TI ANTEGRA-T PLATE-STERILE 37MM-35MM LENGTH-LUMBAR
H981036611390TRIAL ANTEGRA-T PLATE LUMBAR/53MM
H981036611380TRIAL ANTEGRA-T PLATE LUMBAR/51MM
H981036611370TRIAL ANTEGRA-T PLATE LUMBAR/49MM
H981036611360TRIAL ANTEGRA-T PLATE LUMBAR/47MM
H981036611350TRIAL ANTEGRA-T PLATE LUMBAR/45MM
H981036611340TRIAL ANTEGRA-T PLATE LUMBAR/43MM
H981036611330TRIAL ANTEGRA-T PLATE LUMBAR/41MM
H981036611320TRIAL ANTEGRA-T PLATE LUMBAR/39MM
H981036611310TRIAL ANTEGRA-T PLATE LUMBAR/37MM
H981036611090TRIAL ANTEGRA-T PLATE SACRAL/53MM
H981036611080TRIAL ANTEGRA-T PLATE SACRAL/51MM
H981036611070TRIAL ANTEGRA-T PLATE SACRAL/49MM
H981036611060TRIAL ANTEGRA-T PLATE SACRAL/47MM
H981036611050TRIAL ANTEGRA-T PLATE SACRAL/45MM
H981036611040TRIAL ANTEGRA-T PLATE SACRAL/43MM
H981036611030TRIAL ANTEGRA-T PLATE SACRAL/41MM
H981036611020TRIAL ANTEGRA-T PLATE SACRAL/39MM
H981036611010TRIAL ANTEGRA-T PLATE SACRAL/37MM
H981SD036611250ANTEGRA-T TEMPORARY FIXATION PIN-EXTRA LONG
H981SD031610530ANTEGRA-T AWL-EXTRA LONG

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