HWM — Osteotome Class I

FDA Device Classification

FDA product code HWM covers "Osteotome", a Class I medical device regulated under 21 CFR 878.4800. Submissions are reviewed by the General, Plastic Surgery panel. At least 3 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
HWM
Device Class
Class I
Regulation Number
878.4800
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K874503micro-aire surgical instrumentsMICRO-AIRE OSTEOTOME SYSTEM OR BONE HARVESTERDecember 2, 1987
K870780buckman coACROMED WALLIE-HEINIG OSTEOTOMESMarch 9, 1987
K771744depuyOSTEOTOMES FOR CUTTING BONHSeptember 28, 1977