510(k) Report

FDA product code · Orthopedic

Posterior Cervical Screw Placement Guide

QSDClass II21 CFR 888.3075510(k) required2 decisions since 20220 recalls

2 FDA decisions since 2022. 510(k) reviews decided 2021–2025 took a median of 239 days (half between 217 and 260). No recall names this code. The most-cited predicate is K220132, named by 1 later device.

A posterior cervical screw placement guide is intended to be used as a surgical instrument to assist in the intra-operative placement of posterior cervical screws that are used to anchor posterior cervical screw systems on the posterior elements of the spine. The device utilizes anatomic landmarks that are identifiable on pre-operative imaging scans.

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 QSD 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 · QSD

1in 2023

2022: 12023: 1
2007high 1 (2022) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QSD

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

Recalls per year · QSD

No recall names QSD since 2007.

Adverse event reports per year · QSD

No MAUDE report names QSD since 2007.

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—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20221—00
20231—00
20240—00
20250—00
20260—0—
FIG. 1 — QSD by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in QSD? 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 QSD devices cite most?

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

  • K220132FIREFLY® Cervical Navigation GuideMighty Oak Medical, Inc. · 20221cites it

Which QSD devices have the deepest lineage?

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

  • K231515MySpine Cervical GuidesMedacta International S.A. · 202318generations
  • K220132FIREFLY® Cervical Navigation GuideMighty Oak Medical, Inc. · 20225generations

What has FDA decided in QSD lately?

  • K231515MySpine Cervical GuidesMedacta International S.A. · 2023
  • K220132FIREFLY® Cervical Navigation GuideMighty Oak Medical, Inc. · 2022

All 2 QSD decisions →

Related product codes

Other codes under 21 CFR 888.3075.

NKG Posterior Cervical Screw System