VERTEBRAL SPACER-PR 08803037

GUDID H981088030370

VERTEBRAL SPACER-PR 12MMX22MM 17MM HEIGHT

SYNTHES (U.S.A.) LP

Polymeric spinal interbody fusion cage
Primary Device IDH981088030370
NIH Device Record Key6f919cc7-8920-45d6-8d0c-f93c41b10c00
Commercial Distribution Discontinuation2018-12-19
Commercial Distribution StatusNot in Commercial Distribution
Brand NameVERTEBRAL SPACER-PR
Version Model Number08.803.037
Catalog Number08803037
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

Device Identifiers

Device Issuing AgencyDevice ID
GS110705034754253 [Primary]
HIBCCH981088030370 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQPSPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[H981088030370]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2020-02-24
Device Publish Date2015-09-14

On-Brand Devices [VERTEBRAL SPACER-PR]

H9818898490VERTEBRAL SPACER-PR 8MMX22MM 17MM HEIGHT
H9818898480VERTEBRAL SPACER-PR 8MMX22MM 15MM HEIGHT
H9818898470VERTEBRAL SPACER-PR 8MMX22MM 13MM HEIGHT
H9818898460VERTEBRAL SPACER-PR 8MMX22MM 11MM HEIGHT
H9818898450VERTEBRAL SPACER-PR 8MMX22MM 9MM HEIGHT
H9818898440VERTEBRAL SPACER-PR 8MMX22MM 7MM HEIGHT
H981088030470VERTEBRAL SPACER-PR 12MMX24MM 17MM HEIGHT
H981088030460VERTEBRAL SPACER-PR 12MMX24MM 15MM HEIGHT
H981088030450VERTEBRAL SPACER-PR 12MMX24MM 13MM HEIGHT
H981088030440VERTEBRAL SPACER-PR 12MMX24MM 11MM HEIGHT
H981088030430VERTEBRAL SPACER-PR 12MMX24MM 9MM HEIGHT
H981088030420VERTEBRAL SPACER-PR 12MMX24MM 7MM HEIGHT
H981088030370VERTEBRAL SPACER-PR 12MMX22MM 17MM HEIGHT
H981088030360VERTEBRAL SPACER-PR 12MMX22MM 15MM HEIGHT
H981088030350VERTEBRAL SPACER-PR 12MMX22MM 13MM HEIGHT
H981088030340VERTEBRAL SPACER-PR 12MMX22MM 11MM HEIGHT
H981088030330VERTEBRAL SPACER-PR 12MMX22MM 9MM HEIGHT
H981088030320VERTEBRAL SPACER-PR 12MMX22MM 7MM HEIGHT
H981088030270VERTEBRAL SPACER-PR 10MMX24MM 17MM HEIGHT
H981088030260VERTEBRAL SPACER-PR 10MMX24MM 15MM HEIGHT
H981088030250VERTEBRAL SPACER-PR 10MMX24MM 13MM HEIGHT
H981088030240VERTEBRAL SPACER-PR 10MMX24MM 11MM HEIGHT
H981088030230VERTEBRAL SPACER-PR 10MMX24MM 9MM HEIGHT
H981088030220VERTEBRAL SPACER-PR 10MMX24MM 7MM HEIGHT
H981088030170VERTEBRAL SPACER-PR 10MMX22MM 17MM HEIGHT
H981088030160VERTEBRAL SPACER-PR 10MMX22MM 15MM HEIGHT
H981088030150VERTEBRAL SPACER-PR 10MMX22MM 13MM HEIGHT
H981088030140VERTEBRAL SPACER-PR 10MMX22MM 11MM HEIGHT
H981088030130VERTEBRAL SPACER-PR 10MMX22MM 9MM HEIGHT
H981088030120VERTEBRAL SPACER-PR 10MMX22MM 7MM HEIGHT
H981088030070VERTEBRAL SPACER-PR 8MMX24MM 17MM HEIGHT
H981088030060VERTEBRAL SPACER-PR 8MMX24MM 15MM HEIGHT
H981088030050VERTEBRAL SPACER-PR 8MMX24MM 13MM HEIGHT
H981088030040VERTEBRAL SPACER-PR 8MMX24MM 11MM HEIGHT
H981088030030VERTEBRAL SPACER-PR 8MMX24MM 9MM HEIGHT
H981088030020VERTEBRAL SPACER-PR 8MMX24MM 7MM HEIGHT
H981SD3891050PISTOL GRIP IMPLANT HOLDER FOR WIDER VERTEBRAL SPACERS-PR
H981SD3891020STRAIGHT IMPLANT HOLDER FOR WIDER VERTEBRAL SPACERS-PR
H9813050250VERTEBRAL SPACER-PR 12MM X 24MM MODULE CASE
H9813050240VERTEBRAL SPACER-PR 12MM X 22MM MODULE CASE
H9813050230VERTEBRAL SPACER-PR 10MM X 24MM MODULE CASE
H9813050220VERTEBRAL SPACER-PR 10MM X 22MM MODULE CASE
H9813050210VERTEBRAL SPACER-PR 8MM X 24MM MODULE CASE
H9813049210VERTEBRAL SPACER-PR 8MM X 22MM MODULE CASE
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