HWX — Tap, Bone Class I

FDA Device Classification

FDA product code HWX covers "Tap, Bone", a Class I medical device regulated under 21 CFR 888.4540. Submissions are reviewed by the Orthopedic panel. At least 2 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
HWX
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
K873067buckman coACROMED BONE SCREW TAP SLEEVESSeptember 2, 1987
K840735amtech scientificFEMORAL CEMENT REMOVAL INSTRUMENTMay 14, 1984