Aileron TRX

GUDID 00190837137106

Life Spine, Inc.

Interspinous spinal fixation implant
Primary Device ID00190837137106
NIH Device Record Key03c6f738-207b-4727-9ef7-32b4a7ecc41b
Commercial Distribution StatusIn Commercial Distribution
Brand NameAileron TRX
Version Model Number132-2314-2
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100190837137106 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PEKSpinous Process Plate

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00190837137106]

Moist Heat or Steam Sterilization


[00190837137106]

Moist Heat or Steam Sterilization


[00190837137106]

Moist Heat or Steam Sterilization


[00190837137106]

Moist Heat or Steam Sterilization


[00190837137106]

Moist Heat or Steam Sterilization


[00190837137106]

Moist Heat or Steam Sterilization


[00190837137106]

Moist Heat or Steam Sterilization


[00190837137106]

Moist Heat or Steam Sterilization


[00190837137106]

Moist Heat or Steam Sterilization


[00190837137106]

Moist Heat or Steam Sterilization


[00190837137106]

Moist Heat or Steam Sterilization


[00190837137106]

Moist Heat or Steam Sterilization


[00190837137106]

Moist Heat or Steam Sterilization


[00190837137106]

Moist Heat or Steam Sterilization


[00190837137106]

Moist Heat or Steam Sterilization


[00190837137106]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-02-01
Device Publish Date2022-01-24

On-Brand Devices [Aileron TRX]

00190837137106132-2314-2
00190837137090132-2308-2

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