MODIFICATION TO UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW SYSTEM— 510(k) K024313

Name: FDA 510(k) clearance K024313
Creator: U.S. Food and Drug Administration
Published: 2003-08-29

Substantially Equivalent

Pisharodi Surgicals, Inc.

FDA 510(k) clearance K024313 for MODIFICATION TO UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW SYSTEM, Substantially Equivalent on 2003-08-29. Applicant: Pisharodi Surgicals, Inc.. Device class: 2.

Clearance details

Applicant: Pisharodi Surgicals, Inc.
Product code: Code MNI
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 2002-12-24
Decision date: 2003-08-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Round Rock, TX, 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 Pisharodi Surgicals, Inc.

view all

K070335 — SIMPLEX CERVICAL FIXATION SYSTEM2007-04-16
K033951 — RADIX CERVICAL PLATE2004-07-01
K014302 — UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW SYSTEM2002-03-29

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.