Plateau-Z 10mm x 28mm x 15mm, 0°, Titanium

GUDID 00190837018375

Life Spine, Inc.

Metallic spinal fusion cage, non-sterile
Primary Device ID00190837018375
NIH Device Record Key570e83a5-4465-46d2-bd26-7b90c5bc9f79
Commercial Distribution StatusIn Commercial Distribution
Brand NamePlateau-Z 10mm x 28mm x 15mm, 0°, Titanium
Version Model Number43-1028-15T
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 Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100190837018375 [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

[00190837018375]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-12-20

Devices Manufactured by Life Spine, Inc.

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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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