KWJ — Prosthesis, Elbow, Hemi-, Humeral, Metal Class III
FDA product code KWJ covers "Prosthesis, Elbow, Hemi-, Humeral, Metal", a Class III medical device regulated under 21 CFR 888.3180. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants.
Classification Details
- Product Code
- KWJ
- Device Class
- Class III
- Regulation Number
- 888.3180
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Definition
call for pmas to be filed by 12/26/96 per 61 FR 50709 on 9/27/96