ISS — Prosthesis, Thigh Socket, External Component Class I

FDA Device Classification

FDA product code ISS covers "Prosthesis, Thigh Socket, External Component", a Class I medical device regulated under 21 CFR 890.3420. Submissions are reviewed by the Physical Medicine panel. At least 1 recent 510(k) clearance has been granted under this product code.

Classification Details

Product Code
ISS
Device Class
Class I
Regulation Number
890.3420
Submission Type
Review Panel
PM
Medical Specialty
Physical Medicine
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K802911orthomedicsA/K SOCKETDecember 17, 1980