510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K113157Substantially Equivalent

Aileron Interspinous Fixation System

Life Spine, Hoffman Est IL / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K113157 is the FDA 510(k) clearance record for AILERON INTERSPINOUS FIXATION SYSTEM, a class II device, cleared for Life Spine on under FDA product code MNI (Orthosis, Spinal Pedicle Fixation). FDA records list 123 510(k) clearances for Life Spine, from to . As of , FDA records show no recalls naming K113157.

Clearance record

Decision date
Received
(139 days to decision)
Product code
MNI Orthosis, Spinal Pedicle Fixation
Regulation
21 CFR 888.3070
Device class
Class II
Review panel
Orthopedic
Applicant
Life Spine 2401 Hassell Rd. Suite 1535, Hoffman Est IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MNI

Trailing 12 months

FDA records hold no clearances under product code MNI in the trailing twelve months.

FDA records show no clearances under product code MNI in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MNI, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260