HSD

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Product code
HSD
Device name
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Device class
Class 2
21 CFR
21 CFR 888.3690
Medical specialty
Orthopedic
Marketing pathway
510(K)
Flag
Implant
510(k) clearances (last 3 years)
1
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
71 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2024-02-12.

NumberDecision dateApplicantDevice nameSummary
K2332602024-02-12Arthrex, Inc.Univers Revers CA Head and AdapterPDF

1 summaries are archived here for direct download.

Official FDA classification page: HSD
Classification and pathway per current FDA publications. Data from openFDA (CC0).