FDA product code · Orthopedic

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

LGHClass I21 CFR 888.5960510(k) exempt9 decisions since 19820 recalls

FDA lists LGH as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 888.9 applies, such as a new intended use or a different fundamental technology. 9 FDA decisions since 1982. 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 LGH 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 · LGH

FDA has decided no LGH device since 2007.

Median 510(k) review, days · LGH

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

Recalls per year · LGH

No recall names LGH since 2007.

Adverse event reports per year · LGH

5in 2025

2007high 23 (2011) · low 0 (2007)2025

MAUDE reports naming product code LGH, 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	—	0
2008	—	0
2009	—	1
2010	—	6
2011	—	23
2012	—	6
2013	—	12
2014	—	4
2015	—	4
2016	—	2
2017	—	1
2018	—	8
2019	—	2
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	2
2025	—	5
2026	—	—

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

Planning a device in LGH? 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

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