NEW ERA ORTHOPAEDICS POLYSCREW PEDICLE SCREW SYSTEM— 510(k) K141253

Name: FDA 510(k) clearance K141253
Creator: U.S. Food and Drug Administration
Published: 2015-01-09

Substantially Equivalent

New Era Orthopaedics, LLC

FDA 510(k) clearance K141253 for NEW ERA ORTHOPAEDICS POLYSCREW PEDICLE SCREW SYSTEM, Substantially Equivalent on 2015-01-09. Applicant: New Era Orthopaedics, LLC. Device class: 2.

Clearance details

Applicant: New Era Orthopaedics, LLC
Product code: Code MNI
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 2014-05-14
Decision date: 2015-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
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

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 →

Recalls naming K141253

K-number listed on FDA's recall record

Z-2604-2018 — Modera Modular Pedicle Screw System Shank Insertion Instrument, 3-107-07Class II·Terminated·New Era Orthopaedics, LLc·20170213

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K141253.

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