Aileron TRX

GUDID 00190837137090

Life Spine, Inc.

Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant Interspinous spinal fixation implant

Primary Device ID	00190837137090
NIH Device Record Key	950eea72-f242-45cf-bbea-a56c93bcd284
Commercial Distribution Status	In Commercial Distribution
Brand Name	Aileron TRX
Version Model Number	132-2308-2
Company DUNS	183641617
Company Name	Life Spine, Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190837137090 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K100407

FDA Product Code

PEK	Spinous Process Plate