510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K091301Substantially Equivalent

Life Spine Stand-Alone Spacer System

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

K091301 is the FDA 510(k) clearance record for LIFE SPINE STAND-ALONE SPACER SYSTEM, a class II device, cleared for Life Spine on under FDA product code OVD (Intervertebral Fusion Device With Integrated Fixation, Lumbar). FDA's definition for product code OVD reads: "Intended to stabilize lumbar spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation". FDA records list 123 510(k) clearances for Life Spine, from to . As of , FDA records show no recalls naming K091301.

Clearance record

Decision date
Received
(225 days to decision)
Product code
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Regulation
21 CFR 888.3080
Device class
Class II
Review panel
Orthopedic
Applicant
Life Spine 2401 W. Hassell Rd., Hoffman Estates IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OVD

Trailing 12 months
9 clearances under product code OVD in the twelve months to November 2026, July 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code OVD, trailing twelve months
MonthClearances
December 20251
January 20260
February 20261
March 20260
April 20261
May 20261
June 20261
July 20262
August 20261
September 20261
October 20260
November 20260