HSD · Class II · 21 CFR 888.3690

FDA Product Code HSD: Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Leading manufacturers include Arthrex, Inc..

71
Total
71
Cleared
120d
Avg days
1979
Since
Declining activity - 0 submissions in the last 2 years vs 2 in the prior period

FDA 510(k) Cleared Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Devices (Product Code HSD)

71 devices
1–24 of 71
Cleared Feb 12, 2024
Univers Revers CA Head and Adapter
K233260
Arthrex, Inc.
Orthopedic · 136d
Cleared May 19, 2022
Univers Revers Humeral Cup Implant
K221232
Arthrex, Inc.
Orthopedic · 20d

About Product Code HSD - Regulatory Context

510(k) Submission Activity

71 total 510(k) submissions under product code HSD since 1979, with 71 receiving FDA clearance (average review time: 120 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.

HSD devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →