HWA — Impactor Class I

FDA Device Classification

FDA product code HWA covers "Impactor", a Class I medical device regulated under 21 CFR 888.4540. Submissions are reviewed by the Orthopedic panel. At least 4 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
HWA
Device Class
Class I
Regulation Number
888.4540
Submission Type
Review Panel
OR
Medical Specialty
Orthopedic
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K933527miraMODIFICATION OF ANTERIOR SEGMENT ELECTRODESJanuary 25, 1994
K864422cedar surgicalRAYLOR(TM) MALLETNovember 24, 1986
K841627plastafilMALLETAugust 27, 1984
K770205depuyCEMENT CHISELSFebruary 8, 1977