HTG — Prosthesis, Knee, Hemi-, Patellar Resurfacing, Uncemented Class II

FDA Device Classification

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

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K800800waldemar link gmbh and co. kgPATELLAR COMPONENT FOR LUBINUS PATELLARApril 21, 1980
K771708depuyWORRELL PATELLAOctober 6, 1977