KWJClass III

Prosthesis, Elbow, Hemi-, Humeral, Metal

21 CFR 888.3180 / Orthopedic

KWJ is the FDA product code for Prosthesis, Elbow, Hemi-, Humeral, Metal, a class III device type, regulated under 21 CFR 888.3180. FDA's definition for this code reads: "call for pmas to be filed by 12/26/96 per 61 FR 50709 on 9/27/96". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: KWJ
Device name: Prosthesis, Elbow, Hemi-, Humeral, Metal
FDA definition: call for pmas to be filed by 12/26/96 per 61 FR 50709 on 9/27/96
Regulation: 21 CFR 888.3180
Device class: Class III
Review panel: Orthopedic
Submission type: PMA
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

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

Recent clearances

Product code KWJ

FDA records hold no clearances under product code KWJ.

Recent recalls

Product code KWJ

FDA records show no recalls under product code KWJ.

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)