QYQHumanitarian device exemption

Prosthesis, Total Talus Replacement With Soft Tissue Attachment Sites, Metal

Unknown

QYQ is the FDA product code for Prosthesis, Total Talus Replacement With Soft Tissue Attachment Sites, Metal. FDA's definition for this code reads: "Replaces the native talus". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: QYQ
Device name: Prosthesis, Total Talus Replacement With Soft Tissue Attachment Sites, Metal
FDA definition: Replaces the native talus
Device class: Humanitarian device exemption
Review panel: Unknown
Submission type: FDA code 6
Implant: Yes
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

restor3d, Inc.

Recent clearances

Product code QYQ

FDA records hold no clearances under product code QYQ.

Recent recalls

Product code QYQ

FDA records show no recalls under product code QYQ.

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)