Plateau-X Spacer System

GUDID 00190837012939

Life Spine, Inc.

Polymeric spinal interbody fusion cage
Primary Device ID00190837012939
NIH Device Record Keyd274b569-74a0-4add-9aa1-c58b6baa56db
Commercial Distribution StatusIn Commercial Distribution
Brand NamePlateau-X Spacer System
Version Model Number86-2255-711
Company DUNS183641617
Company NameLife Spine, Inc.
Device Count1
DM Exempttrue
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
GS100190837012939 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00190837012939]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-24
Device Publish Date2016-06-14

On-Brand Devices [Plateau-X Spacer System]

0019083701756989-1845-010
0019083701755289-1845-008
0019083701754589-1840-716
0019083701753889-1840-714
0019083701752189-1840-712
0019083701751489-1840-710
0019083701750789-1840-708
0019083701749189-1840-016
0019083701748489-1840-014
0019083701747789-1840-012
0019083701746089-1840-010
0019083701745389-1840-008
0019083701656289-2260-716
0019083701655589-2260-714
0019083701654889-2260-712
0019083701653189-2260-710
0019083701652489-2260-708
0019083701651789-2260-016
0019083701650089-2260-014
0019083701649489-2260-012
0019083701648789-2260-010
0019083701647089-2260-008
0019083701646389-2255-716
0019083701645689-2255-714
0019083701644989-2255-712
0019083701643289-2255-710
0019083701642589-2255-708
0019083701641889-2255-016
0019083701640189-2255-014
0019083701639589-2255-012
0019083701638889-2255-010
0019083701637189-2255-008
0019083701636489-2250-716
0019083701635789-2250-714
0019083701633389-2250-710
0019083701632689-2250-708
0019083701631989-2250-016
0019083701630289-2250-014
0019083701629689-2250-012
0019083701628989-2250-010
0019083701627289-2250-008
0019083701626589-2245-716
00190837016258K121116
0019083701624189-2245-712
0019083701623489-2245-710
0019083701621089-2245-016
0019083701620389-2245-014
0019083701619789-2245-012
0019083701618089-2245-010
0019083701617389-2245-008

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