OSEClass II

Patient Specific Manual Navigation System

21 CFR 882.4560 / Neurology

OSE is the FDA product code for Patient Specific Manual Navigation System, a class II device type, regulated under 21 CFR 882.4560. FDA's definition for this code reads: "Intended for defining implant alignment relative to a patient's anatomy". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: OSE
Device name: Patient Specific Manual Navigation System
FDA definition: Intended for defining implant alignment relative to a patient's anatomy.
Regulation: 21 CFR 882.4560
Device class: Class II
Review panel: Neurology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 0

Companies listing this code with FDA

Companies whose registered establishments list this code

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

Recent clearances

Product code OSE

FDA records hold no clearances under product code OSE.

Recent recalls

Product code OSE

FDA records show no recalls under product code OSE.

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)