HTG — Prosthesis, Knee, Hemi-, Patellar Resurfacing, Uncemented Class II
FDA product code HTG covers "Prosthesis, Knee, Hemi-, Patellar Resurfacing, Uncemented", a Class II medical device regulated under 21 CFR 888.3580. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HTG
- Device Class
- Class II
- Regulation Number
- 888.3580
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes