PAO — Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented Class II
FDA product code PAO covers "Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented", a Class II medical device regulated under 21 CFR 888.3660. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- PAO
- Device Class
- Class II
- Regulation Number
- 888.3660
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Definition
Total shoulders are indicated for arthritis (osteo-, rheumatoid, traumatic), avascular necrosis, correction of functional deformity, and revision procedures.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K201315 | tornier | PERFORM Humeral System Stem | September 11, 2020 |