FDA product code · Orthopedic

Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar

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

NVRClass IIIPMA required6 decisions since 200517 recalls

6 FDA decisions since 2005. 17 recalls name this code, 0 of them Class I. The most-cited predicate is K051320, named by 4 later devices.

Intended to be inserted between the vertebral bodies into the disc space from l3 to s1 to provide stabilization and to help promote intervertebral body fusion. To be used with bone graft, for holding bone parts in alignment while they heal. Not intended for use in motion-sparing, non-fusion procedures, helps promote intervertebral body fusion, please reference…

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 NVR 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 · NVR

2in 2008

2007high 3 (2007) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NVR

298in 2007

2007high 298 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NVR

17in 2007

2007high 17 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NVR

1in 2021

2007high 9 (2008) · low 0 (2010)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	3	298	17	4
2008	2	—	0	9
2009	0	—	0	5
2010	0	—	0	0
2011	0	—	0	3
2012	0	—	0	1
2013	0	—	0	0
2014	0	—	0	0
2015	0	—	0	1
2016	0	—	0	1
2017	0	—	0	1
2018	0	—	0	0
2019	0	—	0	0
2020	0	—	0	0
2021	0	—	0	1
2022	0	—	0	0
2023	0	—	0	0
2024	0	—	0	0
2025	0	—	0	0
2026	0	—	0	—

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

Planning a device in NVR? 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

Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar

Which predicates do NVR devices cite most?

Which NVR devices have the deepest lineage?

What has FDA decided in NVR lately?

What has been recalled in NVR lately?