PZUNot classified

Bone Marrow Processing Device For Clinical Use

Unknown

PZU is the FDA product code for Bone Marrow Processing Device For Clinical Use. FDA's definition for this code reads: "Preparation of concentrated bone marrow aspirate (cBMA) from a sample of bone marrow for clinical use". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: PZU
Device name: Bone Marrow Processing Device For Clinical Use
FDA definition: Preparation of concentrated bone marrow aspirate (cBMA) from a sample of bone marrow for clinical use
Device class: Not classified
Review panel: Unknown
Submission type: Contact ODE
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

Zimmer GmbH

Recent clearances

Product code PZU

FDA records hold no clearances under product code PZU.

Recent recalls

Product code PZU

FDA records show no recalls under product code PZU.

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)