Plateau-Z 10mm x 28mm x 11mm, 0°

GUDID 00190837017743

Life Spine, Inc.

Polymeric spinal interbody fusion cage
Primary Device ID00190837017743
NIH Device Record Keyc918e8c2-a322-4ada-9ffb-8bb2c21412a2
Commercial Distribution StatusIn Commercial Distribution
Brand NamePlateau-Z 10mm x 28mm x 11mm, 0°
Version Model Number43-1028-11
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
GS100190837017743 [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

[00190837017743]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-24
Device Publish Date2016-12-20

Devices Manufactured by Life Spine, Inc.

00190837169428 - TruLift 1-Hole Plate2024-03-28
00190837147327 - ProLift Lateral2024-03-21
00190837171674 - ProLift Lateral2024-03-21
00190837138974 - ProLift2024-02-08
00190837169411 - TruLift 2024-02-02
00190837116248 - Aileron2023-11-16
00190837168322 - ARx2023-11-16
00190837135393 - ARx2023-10-16

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