Plateau-C Spacer System 36-2016-108

GUDID 00190837024451

PLATEAU-C 20mm x 16mm x 8mm Interbody, Biconvex, 0°

Life Spine, Inc.

Polymeric spinal interbody fusion cage
Primary Device ID00190837024451
NIH Device Record Key404c2bc7-cd98-4703-84cb-204a7bb32bed
Commercial Distribution StatusIn Commercial Distribution
Brand NamePlateau-C Spacer System
Version Model Number36-2016-108
Catalog Number36-2016-108
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
GS100190837024451 [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

[00190837024451]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-02-24
Device Publish Date2019-11-14

On-Brand Devices [Plateau-C Spacer System]

0019083701170337-2016-509
0019083701169737-2016-508
0019083701168037-2016-507
0019083701167337-2016-506
0019083701166637-2016-309
0019083701165937-2016-308
0019083701164237-2016-307
0019083701163537-2016-306
0019083701162836-1613-212
0019083701161136-1613-211
0019083701160436-1613-210
0019083701159836-1613-209
0019083701158136-1613-208
0019083701157436-1613-207
0019083701156736-1613-206
0019083701155036-1613-205
0019083701154337-1613-712
0019083701153637-1613-711
0019083701152937-1613-710
0019083701151237-1613-709
0019083701150537-1613-708
0019083701149937-1613-707
0019083701148237-1613-706
0019083701147537-1613-705
0019083701146836-1613-12
0019083701145136-1613-11
0019083701144436-1613-10
0019083701143736-1613-09
0019083701142036-1613-08
0019083701141336-1613-07
0019083701140636-1613-06
0019083701139036-1613-05
0019083701138337-1411-712
0019083701137637-1411-711
0019083701136937-1411-710
0019083701135237-1411-709
0019083701134537-1411-708
0019083701133837-1411-707
0019083701132137-1411-706
0019083701131437-1411-705
0019083701130736-1411-12
0019083701129136-1411-11
0019083701128436-1411-10
0019083701127736-1411-09
0019083701126036-1411-08
0019083701125336-1411-07
0019083701124636-1411-06
0019083701123936-1411-05
00190837024611PLATEAU-C 20mm x 16mm x 14mm Interbody BiConvex, 5°
00190837024604PLATEAU-C 20mm x 16mm x 13mm Interbody BiConvex, 5°

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