MODIFICATION TO LANX SPINAL FIXATION SYSTEM— 510(k) K093285

Name: FDA 510(k) clearance K093285
Creator: U.S. Food and Drug Administration
Published: 2009-12-10

Substantially Equivalent

Lanx, LLC

FDA 510(k) clearance K093285 for MODIFICATION TO LANX SPINAL FIXATION SYSTEM, Substantially Equivalent on 2009-12-10. Applicant: Lanx, LLC. Device class: 2.

Clearance details

Applicant: Lanx, LLC
Product code: Code MNI
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 2009-10-20
Decision date: 2009-12-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Broomfield, CO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MNI

view all

K171497 — Mikron Spinal Fixation System2017-10-12
K160731 — LumFix Spinal Fixation Sytem2016-10-04
K151458 — Double Medical Universal Spine System2016-08-22
K153273 — MySpine Pedicle Screw Placement Guides - LP2016-06-29
K160124 — LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System2016-04-04

More clearances from Lanx, LLC

view all

K120399 — LANX SPINAL FIXATION SYSTEM2012-03-09
K102738 — LANX FUSION SYSTEM2011-02-10
K103040 — LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)2011-02-08
K082774 — LANX CERVICAL INTERVERTEBRAL BODY FUSION DEVICE2008-10-21
K073144 — LANX INTERVERTEBRAL BODY FUSION DEVICE2008-01-24

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.