Aileron Posterior Fusion System

GUDID 00190837000158

Life Spine, Inc.

Interspinous spinal fixation implant
Primary Device ID00190837000158
NIH Device Record Keyd324609d-6ee1-414c-872e-6fa87802850f
Commercial Distribution StatusIn Commercial Distribution
Brand NameAileron Posterior Fusion System
Version Model Number132-528-2
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
GS100190837000158 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PEKSpinous Process Plate

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00190837000158]

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 Posterior Fusion System]

00190837000592132-438-2
00190837000585132-438-1
00190837000578132-436-2
00190837000561132-436-1
00190837000554132-434-2
00190837000547132-434-1
00190837000530132-432-2
00190837000523132-432-1
00190837000516132-430-2
00190837000509132-430-1
00190837000493132-428-2
00190837000486132-428-1
00190837000417132-526-2
00190837000400132-526-1
00190837000394132-518-2
00190837000387132-518-1
00190837000370132-516-2
00190837000363132-516-1
00190837000356132-514-2
00190837000349132-514-1
00190837000332132-512-2
00190837000325132-512-1
00190837000318132-510-2
00190837000301132-510-1
00190837000295132-508-2
00190837000288132-508-1
00190837000271132-506-2
00190837000264132-506-1
00190837000257132-538-2
00190837000240132-538-1
00190837000233132-536-2
00190837000226132-536-1
00190837000219132-534-2
00190837000202132-534-1
00190837000196132-532-2
00190837000189132-532-1
00190837000172132-530-2
00190837000165132-530-1
00190837000158132-528-2
00190837000141132-528-1
00190837091378AO Torque Limit Handle, 20 in-lbs
001908370913611/4" SQ Torque Limit Handle, 20in-lbs
00190837091354SLEEVE, 5MM
00190837091330Aileron Implant/Instrument Tray Base
00190837091323Aileron Implant/Instrument Tray Bottom Level
00190837091316Aileron Implant/Instrument Tray Top Level
00190837091309Aileron Implant/Instrument Tray Lid
00190837091286INTERSPINOUS RASP, 18MM
00190837091279INTERSPINOUS RASP, 16MM
00190837091262INTERSPINOUS RASP, 14MM

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