TSRH SPINAL SYSTEM— 510(k) K032578

Name: FDA 510(k) clearance K032578
Creator: U.S. Food and Drug Administration
Published: 2003-09-17

Substantially Equivalent

Medtronic Sofamor Danek, Inc.

FDA 510(k) clearance K032578 for TSRH SPINAL SYSTEM, Substantially Equivalent on 2003-09-17. Applicant: Medtronic Sofamor Danek, Inc.. Device class: 2.

Clearance details

Applicant: Medtronic Sofamor Danek, Inc.
Product code: Code MNI
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 2003-08-21
Decision date: 2003-09-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Memphis, TN, 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 Medtronic Sofamor Danek, Inc.

view all

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.