DeviceClearance

Product code HSD— Orthopedic

101 NEER TYPE SHOULDER

Classification name
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Device class
Class 2
Regulation
21 CFR 888.3690
Advisory panel
Orthopedic
Total cleared
71
First cleared
Most recent

Market context for product code HSD

FDA has cleared 71 devices under product code HSD between 1979 and 2024, filed by 41 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code HSD

Adverse events under product code HSD

product code HSD
Injury
3,425
Malfunction
531
Total
3,956

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code HSD

Data sourced from openFDA. This site is unofficial and independent of the FDA.