510(k) Report

FDA product code · Orthopedic

Accessories, Fixation, Spinal Interlaminal

LYPClass II21 CFR 888.3050510(k) required1 decision since 19890 recalls

1 FDA decision since 1989. 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 LYP 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 · LYP

FDA has decided no LYP device since 2007.

Median 510(k) review, days · LYP

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

Recalls per year · LYP

No recall names LYP since 2007.

Adverse event reports per year · LYP

2in 2025

2014: 12024: 12025: 2
2007high 2 (2025) · low 0 (2007)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—01
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—01
20250—02
20260—0—
FIG. 1 — LYP by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in LYP? 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

Related product codes

Other codes under 21 CFR 888.3050.