510(k) Report

FDA product code · Orthopedic

Anchor, Suture, Bone Fixation, Metallic

NOVClass II21 CFR 888.3030510(k) required1 decision since 20030 recalls

1 FDA decision since 2003. No recall names this code. The most-cited predicate is K032078, named by 1 later device.

This device is indicated for attaching suture into bone for suspension of the nasal valve and for attaching suture into bone at the lower orbital rim.

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 NOV 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 · NOV

FDA has decided no NOV device since 2007.

Median 510(k) review, days · NOV

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

Recalls per year · NOV

No recall names NOV since 2007.

Adverse event reports per year · NOV

1in 2022

2007: 42008: 42009: 32010: 52011: 12012: 42017: 32018: 12022: 1
2007high 5 (2010) · low 0 (2013)2025

MAUDE reports naming product code NOV, 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—04
20080—04
20090—03
20100—05
20110—01
20120—04
20130—00
20140—00
20150—00
20160—00
20170—03
20180—01
20190—00
20200—00
20210—00
20220—01
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — NOV by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in NOV? 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

Which predicates do NOV devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • K032078Mitek Micro QuickanchorMitek Worldwide · 20031cites it

Which NOV devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K032078Mitek Micro QuickanchorMitek Worldwide · 20031generation

What has FDA decided in NOV lately?

  • K032078Mitek Micro QuickanchorMitek Worldwide · 2003

The one NOV decision →

Related product codes

Other codes under 21 CFR 888.3030.

JDS Nail, Fixation, BoneNDF Plate, Fixation, Bone, Non-Spinal, MetallicOZI Internal Hinged Elbow FixatorOSN Software For Diagnosis/TreatmentOBT Plate, Bone, Growth Control, Pediatric…LRN Wire, SurgicalPLF Bone WedgeHTN Washer, Bolt NutOOL Electronic Depth GaugeMNU Staple, AbsorbableHRS Plate, Fixation, BoneNDG Washer, Bolt, Nut, Non-Spinal, Metallic