Aileron 132-3-033

GUDID 00190837101725

Interspinous Punch 4mm

Life Spine, Inc.

Interspinous spinal fixation implant
Primary Device ID00190837101725
NIH Device Record Key352da6a1-1094-4e36-9eee-e09b9e9ef0aa
Commercial Distribution StatusIn Commercial Distribution
Brand NameAileron
Version Model Number132-3-033
Catalog Number132-3-033
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 Usefalse
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
GS100190837101725 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PEKSpinous process plate

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00190837101725]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-27
Device Publish Date2019-11-19

On-Brand Devices [Aileron]

00190837091507HEX DRIVER AILERON
00190837091491PUNCH, AILERON, LARGE
00190837091484PUNCH, AILERON, MEDIUM
00190837091477PUNCH, AILERON, SMALL
00190837091460SLEEVE, 18MM
00190837091453SLEEVE, 16MM
00190837091439SLEEVE, 12MM
00190837091422SLEEVE, 10MM
00190837091415SLEEVE, 7MM
00190837091408SLEEVE, 5MM
00190837091385Static Aileron Implant Caddy - Small
00190837091347All-In-One Inserter, Aileron TRX
00190837091293VICE GRIPS
00190837043667Punch, Aileron, Medium
00190837043513Static Aileron Implant Caddy - Small
00190837101732Interspinous Punch 6mm
00190837101725Interspinous Punch 4mm
00190837101718Interspinous Rasp, 18mm
00190837101701Interspinous Rasp, 16mm
00190837101695Interspinous Rasp, 14mm
00190837101688Interspinous Rasp, 12mm
00190837101671Interspinous Rasp, 10mm
00190837101664Interspinous Rasp, 8mm
00190837101657Interspinous Rasp, 6mm
00190837101640Interspinous Rasp, 4mm
00190837091446SLEEVE, 14MM

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