LIFE SPINE INTERSPINOUS FIXATION SYSTEM— 510(k) K100407

Name: FDA 510(k) clearance K100407
Creator: U.S. Food and Drug Administration
Published: 2010-11-05

Substantially Equivalent

Life Spine

FDA 510(k) clearance K100407 for LIFE SPINE INTERSPINOUS FIXATION SYSTEM, Substantially Equivalent on 2010-11-05. Applicant: Life Spine. Device class: 2.

Clearance details

Applicant: Life Spine
Product code: Code MNI
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 2010-02-16
Decision date: 2010-11-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hoffman Estates, IL, US

Download summary PDF View on FDA.gov ↗

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K151458 — Double Medical Universal Spine System2016-08-22
K153273 — MySpine Pedicle Screw Placement Guides - LP2016-06-29
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K150368 — Tarsa-Link Wedge Fixation System2015-03-24
K141905 — PRO-LINK WEDGE SYSTEM2014-09-26
K133717 — LONGBOW SPACER SYSTEM2014-09-19

Adverse events under product code MNI

product code MNI

Injury: 641
Total: 641

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.