HSD
- 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)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K233260 | 2024-02-12 | Arthrex, Inc. | Univers Revers CA Head and Adapter |
Official FDA classification page: HSD
Classification and pathway per current FDA publications. Data from openFDA (CC0).