HWK — Trephine Class I

FDA Device Classification

FDA product code HWK covers "Trephine", a Class I medical device regulated under 21 CFR 888.4540. Submissions are reviewed by the Orthopedic panel. At least 1 recent 510(k) clearance has been granted under this product code.

Classification Details

Product Code
HWK
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
K851339conceptPRECISION HARVEST & INLAY INSTRUMENT SETJuly 2, 1985