FDA product code · Orthopedic

Spinal Pedicle Screw, Fixation, Appliance System

Name: FDA decisions, review times, recalls and adverse event reports for product code MCV
Creator: 510(k) Report

MCVClass IIIPMA required0 decisions since 19990 recalls

0 FDA decisions since 1999. No recall names this code.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, orthopedic panel

Twenty years of MCV at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · MCV

FDA has decided no MCV device since 2007.

Median 510(k) review, days · MCV

Too few MCV 510(k)s in any year since 2007 to give a median.

Recalls per year · MCV

No recall names MCV since 2007.

Adverse event reports per year · MCV

1in 2019

2007high 83 (2013) · low 0 (2017)2025

MAUDE reports naming product code MCV, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	69
2008	—	52
2009	—	25
2010	—	11
2011	—	1
2012	—	8
2013	—	83
2014	—	30
2015	—	2
2016	—	1
2017	—	0
2018	—	0
2019	—	1
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

FIG. 1 — MCV by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in MCV? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report