Plateau-C Ti 36-1411-209

GUDID 00190837022204

14mm X 11mm X 9mm Plateau-C Spacer, Bi-Convex

Life Spine, Inc.

Polymeric spinal interbody fusion cage
Primary Device ID00190837022204
NIH Device Record Key5ac6f01c-4ca0-486d-b3a7-a4c4d2535794
Commercial Distribution StatusIn Commercial Distribution
Brand NamePlateau-C Ti
Version Model Number36-1411-209
Catalog Number36-1411-209
Company DUNS183641617
Company NameLife Spine, Inc.
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100190837022204 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ODPIntervertebral fusion device with bone graft, cervical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00190837022204]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-02-24
Device Publish Date2019-11-07

On-Brand Devices [Plateau-C Ti]

0019083701975436-1613-212T
0019083701974736-1613-211T
0019083701973036-1613-210T
0019083701972336-1613-209T
0019083701971636-1613-208T
0019083701970936-1613-207T
0019083701969336-1613-206T
0019083701968636-1613-205T
0019083701967937-1613-712T
0019083701966237-1613-711T
0019083701965537-1613-710T
0019083701964837-1613-709T
0019083701963137-1613-708T
0019083701962437-1613-707T
0019083701961737-1613-706T
0019083701960037-1613-705T
0019083701959436-1613-12T
0019083701958736-1613-11T
0019083701957036-1613-10T
0019083701956336-1613-09T
0019083701955636-1613-08T
0019083701954936-1613-07T
0019083701953236-1613-06T
0019083701952536-1613-05T
0019083701951836-1411-212T
0019083701950136-1411-211T
0019083701949536-1411-210T
0019083701948836-1411-209T
0019083701947136-1411-208T
0019083701946436-1411-207T
0019083701945736-1411-206T
0019083701944036-1411-205T
0019083701943337-1411-712T
0019083701942637-1411-711T
0019083701941937-1411-710T
0019083701940237-1411-709T
0019083701939637-1411-708T
0019083701938937-1411-707T
0019083701937237-1411-706T
0019083701936537-1411-705T
0019083701935836-1411-12T
0019083701934136-1411-11T
0019083701933436-1411-10T
0019083701932736-1411-09T
0019083701931036-1411-08T
0019083701930336-1411-07T
0019083701929736-1411-06T
0019083701928036-1411-05T
00190837068646Cervical Tamp
0019083706863916x13 Rasp / Trial 12mm, 7 Degree, w/Stop

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