QHQ — Total Shoulder Arthroplasty System Class II
FDA product code QHQ covers "Total Shoulder Arthroplasty System", 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
- QHQ
- Device Class
- Class II
- Regulation Number
- 888.3660
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Definition
To treat pain and lack of function in the shoulder.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K183194 | arthrex | Arthrex Eclipse Shoulder Prosthesis System | July 26, 2019 |