NDEClass II

Rod, Fixation, Intramedullary And Accessories, Metallic And Non-Collapsible

21 CFR 888.3020 / Orthopedic

NDE is the FDA product code for Rod, Fixation, Intramedullary And Accessories, Metallic And Non-Collapsible, a class II device type, regulated under 21 CFR 888.3020. As of 2026-09-10, FDA records hold no 510(k) clearances under this code and one recall.

Classification record

Product code: NDE
Device name: Rod, Fixation, Intramedullary And Accessories, Metallic And Non-Collapsible
Regulation: 21 CFR 888.3020
Device class: Class II
Review panel: Orthopedic
Submission type: 510(k)
Implant: Yes
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code NDE.

Recent clearances

Product code NDE

FDA records hold no clearances under product code NDE.

Recent recalls

Product code NDE

Z-0880-2017Class IIA review of packaging revealed the seal integrity of the pouch may be compromised. More specifically, there is a potential that...Stryker Howmedica Osteonics Corp. / initiated 2016-11-09 / 2,084 units

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)