Aileron-TRX Expandable Posterior Fusion System

GUDID 00190837000479

Life Spine, Inc.

Interspinous spinal fixation implant
Primary Device ID00190837000479
NIH Device Record Key4e2f8284-17b0-4d0a-a9c3-d9d03f82a19e
Commercial Distribution StatusIn Commercial Distribution
Brand NameAileron-TRX Expandable Posterior Fusion System
Version Model Number132-2318-2
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
GS100190837000479 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PEKSpinous Process Plate

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00190837000479]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-04-23
Device Publish Date2016-06-06

On-Brand Devices [Aileron-TRX Expandable Posterior Fusion System]

00190837000479132-2318-2
00190837000462132-2318-1
00190837000455132-2314-2
00190837000448132-2314-1
00190837000431132-2308-2
00190837000424132-2308-1

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