KYM — Metallic Cemented Glenoid Hemi-Shoulder Prosthesis Class III
FDA product code KYM covers "Metallic Cemented Glenoid Hemi-Shoulder Prosthesis", a Class III medical device regulated under 21 CFR 888.3680. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants.
Classification Details
- Product Code
- KYM
- Device Class
- Class III
- Regulation Number
- 888.3680
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Definition
Call for pmas to be filed by 12/26/96 per 61 fr 50711 on 9/27/96