MEGA 5.5 SPINE SYSTEM— 510(k) K123476

Name: FDA 510(k) clearance K123476
Creator: U.S. Food and Drug Administration
Published: 2013-01-08

Substantially Equivalent

Lsk Biopartners, Inc.

FDA 510(k) clearance K123476 for MEGA 5.5 SPINE SYSTEM, Substantially Equivalent on 2013-01-08. Applicant: Lsk Biopartners, Inc.. Device class: 2.

Clearance details

Applicant: Lsk Biopartners, Inc.
Product code: Code MNH
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 2012-11-13
Decision date: 2013-01-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MNH

view all

K162066 — Reliance Spinal Screw System2016-12-02
K162801 — CastleLoc Spinal Fixation System2016-11-03
K162143 — FixxSure® X-Link2016-09-23
K161151 — Spinal fixation system2016-09-21
K162189 — ANAX 5.5 Spinal System2016-08-30

Adverse events under product code MNH

product code MNH

Injury: 978
Malfunction: 793
Total: 1,771

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.